MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT CAGE DIAM 22 X 32 MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	48292232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded.
Event or Problem Description
It was reported that a vlift cage securing mechanism fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully with a 40 minute surgical delay.
Additional Manufacturer Narrative
Corrected data: d3 was corrected from 'stryker spine-france' to 'stryker spine-us'.Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Root cause could not be determined conclusively, but may have occurred due to excess force applied while rotating the locking screw or over torquing of locking screw.
Event or Problem Description
It was reported that a vlift cage securing mechanism fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully with a 40 minute surgical delay.

• Brand Name: VLIFT CAGE DIAM 22 X 32 MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10089767
• Report Number: 0009617544-2020-00077
• Device Sequence Number: 19545736
• Product Code: MQP
• UDI-Device Identifier: 04546540557865
• UDI-Public: 04546540557865
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 09/29/2020

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: Health Professional
• Device Model Number: 48292232
• Device Catalogue Number: 48292232
• Device Lot Number: 192197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1