MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 2 LEVEL ACP SIZE 37MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48651237
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during medical procedure surgeon used a two level plate, after location used a xray two verify position of screws and decide to remove them due to they are too short using the same screwdriver used to introduce them.The first screw from inferior side was unable to extract as well as one screw in superior side, the other 2 screws were removed without issues.The surgeon decide to use two new larger screws in order to fix the plate to the bone.
Additional Manufacturer Narrative
Device history review, complaint history review, risk assessment manufacturing records for this product were reviewed and no anomalies were found.Possible root causes include: excessive axial/torsional force applied during screw insertion.Locking ring deformed/damaged.Draw rod tip fractured/remains in screw head.
Event or Problem Description
It was reported that; during medical procedure surgeon used a two level plate, after location used a xray two verify position of screws and decide to remove them due to they are too short using the same screwdriver used to introduce them.The first screw from inferior side was unable to extract as well as one screw in superior side, the other 2 screws were removed without issues.The surgeon decide to use two new larger screws in order to fix the plate to the bone.

• Brand Name: REFLEX-HYBRID 2 LEVEL ACP SIZE 37MM
• 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: 6282714
• Report Number: 0009617544-2017-00036
• Device Sequence Number: 1502487
• Product Code: KWQ
• UDI-Device Identifier: 04546540534835
• UDI-Public: (01)04546540534835
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K04026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: 48651237
• Device Lot Number: 151253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1