MAUDE Adverse Event Report: STRYKER SPINE-US AVS TL SPACER 9 X 30 X 4 DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48370094
Medical Device Problem Codes	Material Deformation (2976); Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status of the device is unknown.
Event or Problem Description
It was reported that an avs tl spacer disengaged intra-operatively while attempting to insert at l4/5 level.
Additional Manufacturer Narrative
Correction to h6, device code grid, from 'separation problem' to 'material deformation'.Visual inspection: the area around the threading is found to be deformed, likely due to force applied in an attempt to insert/thread the inserter into the cage.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.An exact root cause could not be determined, but may have occurred due to excessive or incorrect force applied during attachment of the implant to the inserter.
Event or Problem Description
It was reported that an avs tl spacer disengaged intra-operatively from the inserter while attempting to insert at the l4/5 level.There were no adverse consequences to the patient.The procedure was completed successfully by using a curved inserter and a different cage.

• Brand Name: AVS TL SPACER 9 X 30 X 4 DEG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9829334
• Report Number: 0009617544-2020-00038
• Device Sequence Number: 16328885
• Product Code: MAX
• UDI-Device Identifier: 07613153046400
• UDI-Public: 07613153046400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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: No Information
• Device Model Number: 48370094
• Device Catalogue Number: 48370094
• Device Lot Number: 28429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1