MAUDE Adverse Event Report: STRYKER SPINE-FRANCE VLIFT CAGE DIAM 18 X 25MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48291825
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when trying to lock the lift cage, it would not engage, and upon removal noticed it was stripped.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: no manufacturing issues were discovered.All units were designed according to stryker specifications.According to the stg, there is no tactile feedback during the locking step and it was reported that "surgeon said it felt like the screw was stripped".Conclusion: the probable root cause is relying on tactical feedback for the locking screw.
Event or Problem Description
It was reported that; when trying to lock the lift cage, it would not engage, and upon removal noticed it was stripped.

• Brand Name: VLIFT CAGE DIAM 18 X 25MM
• 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: 5680455
• Report Number: 0009617544-2016-00210
• Device Sequence Number: 212715
• Product Code: MQP
• UDI-Device Identifier: 04546540557810
• UDI-Public: (01)04546540557810
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2016

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: 48291825
• Device Lot Number: 15A167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1