MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT CAGE DIAM 18 X 20MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	48291820
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Device remains implanted.
Event or Problem Description
It was reported that when the gold screw of the cage was final tightened by counterclockwise movement, as specified in the surgical technique, a part of the screw broke.Because the screw breakage was partial, the surgeon continued with final tightening.It was discovered that prior to implantation, the surgeon accidentally turned the screw clockwise which is not specified in the surgical technique.There were no adverse consequences to the patient.
Event or Problem Description
It was reported that when the gold screw of the cage was final tightened by counterclockwise movement, as specified in the surgical technique, a part of the screw broke.Because the screw breakage was partial, the surgeon continued with final tightening.It was discovered that prior to implantation, the surgeon accidentally turned the screw clockwise which is not specified in the surgical technique.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event of was confirmed via email correspondence with the sales rep.All fragments were retrieved and surgery was completed successfully.The device was not returned - still implanted, therefore device evaluation could not be performed.Manufacturing history review revealed no relevant anomalies.Conclusion: some plausible root cause of the screw fractures are : excessive torque applied during implant expansion in-situ, user applies off-axis loading during expansion, inserter not assembles correctly to implant.However the exact root cause cannot be confirmed without device evaluation.

• Brand Name: VLIFT CAGE DIAM 18 X 20MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7898541
• Report Number: 0009617544-2018-00227
• Device Sequence Number: 1473184
• Product Code: MQP
• UDI-Device Identifier: 04546540557803
• UDI-Public: 04546540557803
• Combination Product (Y/N): N
• PMA/510(K) Number: K060506
• 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): 11/21/2018

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: 48291820
• Device Lot Number: 176401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 10/27/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1