# FDA 483 - Stryker Craniomaxillofacial Division - December 10, 2008

Source: https://www.globalkeysolutions.net/records/483/stryker-craniomaxillofacial-division/76f9a85e-f66a-41f4-87ce-5c28b208f4f4

> FDA 483 for Stryker Craniomaxillofacial Division on December 10, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stryker Craniomaxillofacial Division
- Inspection Date: 2008-12-10
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: During an inspection conducted by the FDA from November 8 to December 10, 2008, the Stryker Craniomaxillofacial Division, a medical device distributor, received an FDA Form 483 detailing significant observations regarding its quality system. The primary issue identified was the company's failure to adequately implement complaint handling procedures, leading to inconsistent and untimely processing of reported product issues.

Specifically, the inspection noted instances where complaints were not entered into the system promptly. For example, a complaint received on August 7, 2008, concerning an infection with a BoneSource Classic product, was not recorded until August 13. Similarly, an infection and revision surgery complaint for an Extra Large Custom Cranial Implant, received on September 15, 2008, was only entered on October 13. A separate incident involving a broken Cannulated Screwdriver Blade also highlighted procedural inconsistencies. These delays and inconsistencies indicate non-compliance with established quality system requirements for medical device distributors, which mandate robust and timely complaint management.

As an FDA Form 483 is an advisory document outlining objectionable conditions, Stryker Craniomaxillofacial Division is expected to promptly address these observations by developing and implementing comprehensive corrective actions. These actions must ensure that all future complaints are processed uniformly and within appropriate timeframes, thereby adhering to regulatory standards and ensuring product safety and quality.

## Related Documents

- [483 - 2008-12-10](https://www.globalkeysolutions.net/records/483/stryker-craniomaxillofacial-division/a3b71705-6025-4c7d-82d6-9257141242bc)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/gary-d-urbiel-goldner/03be1e19-67a3-4b60-b9fb-cc106f426de1)
- [ Director, Bioresearch Monitoring Division (West) and FDA Delegate to the OECD Working Party on GLPs](https://www.globalkeysolutions.net/people/eric-s-pittman/878b3087-615d-4e1f-9a9f-0649b46b817b)
- [Investigator ](https://www.globalkeysolutions.net/people/william-d-tingley/cb649d5f-aef1-4e8e-871f-42744541f2bf)

Company: https://www.globalkeysolutions.net/companies/stryker-craniomaxillofacial-division/920c1df1-ec95-4c6a-948a-3f6f4297c5c5

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7