MAUDE Adverse Event Report: STRYKER SPINE-US AERO LL FIXATION ANCHOR, 50MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number	48940050
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor was damaged(bent upward) while inserting at l3 vertebrae.The surgeon removed the anchor and tried using second anchor which was deformed again.The surgeon decided not to place blade on the superior level.The surgeon was content with the amount of fixation and completed surgery successfully (facet fusion with micro decompression on the posterior side) using another anchor.It was also reported that the patient had concrete bone quality and the surgeon attributed much of event to the bone quality of the patient.A surgical delay of close to an hour was reported.No other adverse consequence to the patient was reported.
Additional Manufacturer Narrative
The returned anchor still embedded inside the cage, was confirmed to be a concomitant product.Concomitant product.
Event or Problem Description
It was reported that the anchor was damaged(bent upward) while inserting at l3 vertebrae.The surgeon removed the anchor and tried using second anchor which was deformed again.The surgeon decided not to place blade on the superior level.The surgeon was content with the amount of fixation and completed surgery successfully (facet fusion with micro decompression on the posterior side) using another anchor.It was also reported that the patient had concrete bone quality and the surgeon attributed much of event to the bone quality of the patient.A surgical delay of close to an hour was reported.No other adverse consequence to the patient was reported.

• Brand Name: AERO LL FIXATION ANCHOR, 50MM
• 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: 8447890
• Report Number: 0009617544-2019-00033
• Device Sequence Number: 3219112
• Product Code: OVD
• UDI-Device Identifier: 07613327066173
• UDI-Public: 07613327066173
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142066
• 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): 05/17/2019

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: 48940050
• Device Lot Number: 14G499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR