MAUDE Adverse Event Report: STRYKER SPINE-FRANCE VLIFT CAGE DIAM 22 X 32 MM; INTERVERTEBRAL BODY FUSION DEVICE.

Model Number	48292232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor used a loan kit in order to perform a corporectomy l1.When the cage was fitted with the 22x3deg and 22x0deg plugs and more precisely at the time of its insertion, the screw thread of the inner shaft of the inserter broke and remained stuck in the thread of the cage (thread accommodating the insert).The surgeon took the decision to remove the cage in order to not leave the element in place.Then the surgeon decided to replace the cage by an iliac crest graft of the patient.The cage inserter being broken, it was difficult to use it to insert the new cage.Since the size of the graft taken was insufficient in view of the intervertebral space, the doctor decided to insert a new cage using the broken inserter.The insertion was possible.This event led to a surgical delay of 1 hour and 45 minutes.
Additional Manufacturer Narrative
Lot #: 160150 no issue was reported on this device as this is a concomitant product.No issue was reported on this device as this is a concomitant product.
Event or Problem Description
It was reported that the doctor used a loan kit in order to perform a corporectomy l1.When the cage was fitted with the 22x3deg and 22x0deg plugs and more precisely at the time of its insertion, the screw thread of the inner shaft of the inserter broke and remained stuck in the thread of the cage (thread accommodating the insert).The surgeon took the decision to remove the cage in order to not leave the element in place.Then the surgeon decided to replace the cage by an iliac crest graft of the patient.The cage inserter being broken, it was difficult to use it to insert the new cage.Since the size of the graft taken was insufficient in view of the intervertebral space, the doctor decided to insert a new cage using the broken inserter.The insertion was possible.This event led to a surgical delay of 1 hour and 45 minutes.

• Brand Name: VLIFT CAGE DIAM 22 X 32 MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6787643
• Report Number: 0009617544-2017-00318
• Device Sequence Number: 11155282
• Product Code: MAX
• UDI-Device Identifier: 04546540557865
• UDI-Public: (01)04546540557865
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/07/2017

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: 48292232
• Device Catalogue Number: 48292232
• Device Lot Number: 160150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1