MAUDE Adverse Event Report: STRYKER SPINE-US AVS TL SPACER 9 X 25 X 4 DEG; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number	48375094
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	11/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The cage broke during surgery, broken fragments were retrieved.Replacement cage was used to complete the surgery.10 minute surgical delay was reported.No adverse consequences to the patient has been reported.
Event or Problem Description
The cage broke during surgery, broken fragments were retrieved.Replacement cage was used to complete the surgery.10 minute surgical delay was reported.No adverse consequences to the patient has been reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via visual inspection of returned product.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was also reported that the cage was impacted with straight impactor via high amount of force.Conclusion: the root cause of the reported event was determined to be user error- too much impaction force.

• Brand Name: AVS TL SPACER 9 X 25 X 4 DEG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8125579
• Report Number: 0009617544-2018-00288
• Device Sequence Number: 2080926
• Product Code: OVD
• UDI-Device Identifier: 07613153046646
• UDI-Public: 07613153046646
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143163
• 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): 03/18/2019

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 Catalogue Number: 48375094
• Device Lot Number: 84576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1