MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 2 LEVEL ACP SIZE 30MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48651230
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gold locking ring on 30mm plate was extracted during removal of screw, had to remove the plate and replace to achieve final tightening/locking.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was not confirmed to have any locking ring of the plate deformed through visual examination.Manufacturing records for this product were reviewed and no anomalies were found.The root cause of the reported event is not determined.
Event or Problem Description
It was reported that the gold locking ring on 30mm plate was extracted during removal of screw, had to remove the plate and replace to achieve final tightening/locking.

• Brand Name: REFLEX-HYBRID 2 LEVEL ACP SIZE 30MM
• 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: 6142589
• Report Number: 0009617544-2016-00480
• Device Sequence Number: 19071341
• Product Code: KWQ
• UDI-Device Identifier: 04546540534804
• UDI-Public: (01)04546540534804
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48651230
• Device Lot Number: 14G865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1