MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 2 LEVEL ACP SIZE 34MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48651234
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the patient did the anterior cervical fusion surgery in (b)(6) 2016; when he did examination in (b)(6) 2016, the doctor found the screw exited from the plate.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the stryker rep was not able to obtain any additional information on this case.X-rays were reviewed and exhibited a screw that had backed out of the plate.Op notes were provided and did provide any details on the patient's health or pathology, the notes only discussed anesthesia, surgical time and where incisions were made.The possible root causes of this range from patient activity, poor bone quality and disease, however this information was not able to be obtained at the time of this report.Conclusion: the root cause is not determined and multifactorial.
Event or Problem Description
It was reported that; the patient did the anterior cervical fusion surgery in (b)(6) 2016; when he did examination in (b)(6) 2016, the doctor found the screw exited from the plate.

• Brand Name: REFLEX-HYBRID 2 LEVEL ACP SIZE 34MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5514956
• Report Number: 0009617544-2016-00127
• Device Sequence Number: 340766
• Product Code: KWQ
• UDI-Device Identifier: 04546540534828
• UDI-Public: (01)04546540534828
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48651234
• Device Lot Number: 14G889
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 06/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR