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

Model Number	48651230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that while inserting the last screw on a plate the surgeon noticed the screw wasn't going below the ring.The surgeon tried redirecting the screw two times and the medial part of the ring in the hole was still not able to be seen.The surgeon was unsure if the ring was present and therefore decided to remove the plate.The surgeon saw that there was a ring but the ring was wedged/jammed and there was no give.New plate same size was implanted.No adverse consequences to the patient reported.Additionally, while removing the screw to remove the plate, the tip of the revision driver broke.All broken fragments were retrieved and the tip of the driver remains in the screw.The driver has been used several times.¿.
Additional Manufacturer Narrative
Lot# 168707.No manufacturing issues were found for this lot number.The returned plate did not exhibit ring damage for the implanted screw, and appeared normal.The root cause of the event is not determined.
Event or Problem Description
It is reported that while inserting the last screw on a plate the surgeon noticed the screw wasn't going below the ring.The surgeon tried redirecting the screw two times and the medial part of the ring in the hole was still not able to be seen.The surgeon was unsure if the ring was present and therefore decided to remove the plate.The surgeon saw that there was a ring but the ring was wedged/jammed and there was no give.New plate same size was implanted.No adverse consequences to the patient reported.Additionally, while removing the screw to remove the plate, the tip of the revision driver broke.All broken fragments were retrieved and the tip of the driver remains in the screw.The driver has been used several times.¿.

• 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: 6755575
• Report Number: 0009617544-2017-00295
• Device Sequence Number: 1540498
• Product Code: KWQ
• UDI-Device Identifier: 04546540534804
• UDI-Public: (01)04546540534804
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K040261
• 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): 10/18/2017

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 Model Number: 48651230
• Device Catalogue Number: 48651230
• Device Lot Number: 168707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 89