MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 4X12MM VARIABLE ANGLE SELF TAP.SCREW; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48694012
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; (b)(6) 2016, implanted four screws and the 2 level plate on c3-5.On (b)(6) 2017, it was informed the screw of c5 right was out.On (b)(6) 2017 it was surgical treatment for screw out.
Additional Manufacturer Narrative
Catalog# 48694012.Lot# fgp.Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records for this product were not reviewed because no lot numbers were provided as the parts remain implanted.Visual-x rays were provided and showed one screw backing out of the plate.Conclusion: the root cause could not be determined.
Event or Problem Description
It was reported that; (b)(6) 2016, implanted four screws and the 2 level plate on c3-5.On (b)(6) 2017, it was informed the screw of c5 right was out.On (b)(6) 2017 it was surgical treatment for screw out.

• Brand Name: REFLEX-HYBRID 4X12MM VARIABLE ANGLE SELF TAP.SCREW
• 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: 6340632
• Report Number: 0009617544-2017-00060
• Device Sequence Number: 16558808
• Product Code: KWQ
• UDI-Device Identifier: 04546540534828
• UDI-Public: (01)04546540534828
• Combination Product (Y/N): N
• PMA/510(K) Number: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

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: 48694012
• Device Lot Number: FGP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 04/27/2017
• 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: Required Intervention
• Patient Age: 63 YR