MAUDE Adverse Event Report: STRYKER SPINE-US AVS TL SPACER 10 X 30 X 4 DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48370104
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of the device/devices is currently unknown.
Event or Problem Description
An avs tl spacer disengaged from the inserter into the disc space without prompt from the surgeon.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained because the device associated with this event was not returned.It was reported that the cage was being inserted using an angled tl inserter when the cage detached and released into the disc space without any prior prompt to do so by the surgeon.The device was not returned.Cage was intact and did not acquire any damage/ fracture.Inserter was tested and confirmed to be in good condition.Disc space was sufficient to accommodate implant.Same sized implant was used to successfully complete the procedure using a straight inserter.The avs tl spacer surgical technique was reviewed and the following relevant information was identified: slide the collet into the insertion hole of the avs tl implant.Close the lever on the handle and the collect expands, capturing the avs tl implant.Note: it is recommended that all inserters are lubricated regularly.Risk table states that improper implant attachment to inserter may result in implant fall during insertion.Based on available information and risk table, most likely cause of reported event is improper implant-inserter attachment.Insufficient torque or improper mating between implant and distal tip of inserter may lead to improper attachment between implant and inserter.H3 other text : device not returned.
Event or Problem Description
An avs tl spacer disengaged from the inserter into the disc space without prompt from the surgeon.

• Brand Name: AVS TL SPACER 10 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: 9269235
• Report Number: 0009617544-2019-00120
• Device Sequence Number: 13544656
• Product Code: MAX
• UDI-Device Identifier: 07613153046424
• UDI-Public: 07613153046424
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/19/2020

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: 48370104
• Device Catalogue Number: 48370104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1