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

Model Number	48651230
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon performed a c3-c5 acdf on (b)(6) 2017 utilizing reflex hybrid.In the patient's follow up scans, it can be seen that the screw inserted at the c3 level has passed through the plate and locking mechanism.The plate is now migrating anteriorly.At this time, the patient is not experiencing any discomfort or pain, but the fact the screw is no longer attached to the plate is a concern.
Additional Manufacturer Narrative
Method: risk assessment.Result: manufacturing records for this product were not reviewed because no lot numbers were provided as the parts remain implanted.Conclusion: the possible root causes of this range from all screws not placed into plate; screw back-out; locking ring not visually checked after final tightening; fatigue loading.
Event or Problem Description
It was reported that; surgeon performed a c3-c5 acdf on (b)(6) 2017 utilizing reflex hybrid.In the patient's follow up scans, it can be seen that the screw inserted at the c3 level has passed through the plate and locking mechanism.The plate is now migrating anteriorly.At this time, the patient is not experiencing any discomfort or pain, but the fact the screw is no longer attached to the plate is a concern.

• 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: 6659893
• Report Number: 0009617544-2017-00254
• Device Sequence Number: 16496982
• 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: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1