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 Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during a 2l acf, as dr was removing the drill guide from the hybrid plate, he noticed it damaged the ring.Had to change plate.So as he is removing the screws, part of the thread of one of the vast screws came off.He retrieved all of it.Used the same size plate and finished the procedure.Delay of 4-5 minutes.
Additional Manufacturer Narrative
Visual inspection; functional inspection; device history review; complaint history review; risk assessment; the returned plate was found to have a locking ring migrating out of the plate consistent with a forceful removal of a drill guide.Manufacturing records for this product were reviewed and no anomalies were found.The stryker rep reported that the screw holes were prepared using a drill guide and bit and that the ring was deformed upon removal of the guide.The probable root cause of the ring deformation is over angulation of the drill guide during removal.
Event or Problem Description
It was reported that; during a 2l acf, as dr was removing the drill guide from the hybrid plate, he noticed it damaged the ring.Had to change plate.So as he is removing the screws, part of the thread of one of the vast screws came off.He retrieved all of it.Used the same size plate and finished the procedure.Delay of 4-5 minutes.

• 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: 5464020
• Report Number: 0009617544-2016-00084
• Device Sequence Number: 405093
• Product Code: KWQ
• UDI-Device Identifier: 04546540534835
• UDI-Public: (01)04546540534835
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K063430
• 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): 02/02/2016

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: 065740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2016
• Supplement Report FDA Received Date: 05/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1