MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL LUMBAR CAGE 22 X 28MM, 11MM, 04 DEG.; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48922214
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon experienced difficulty inserting the anchor (superior patient left anchor).During insertion of the anchor into the cut track, it went into the device and locked into the implant, however it skived off the endplate and did not go into the vertebral body.The entire implant was then removed.Second attempt with a new implant same size; all 3 other anchors were inserted successfully.The superior anchor was left for last, surgeon had the same issue.Upon insertion of the anchor he could not get the anchor to advance all the way.He then removed the insertion guide and tried to freehand tamp the anchor and the anterior aspect of the device bent.A 3mm of the anchor was protruding anteriorly to the device.Surgeon did not want to remove the entire device and therefore decided to use a metal cutting burr to grind away protruding anchor, leaving the majority of the anchor in the patient.All 3 other anchors went through easily, the patient's bone quality was very hard at the specific region where the 4th anchor would not go in.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Anchor deformation intra-op was confirmed via visual inspection.Conclusion: the plausible root cause is likely related to (1) patient's very hard bone; (2) over impaction during the pilot cutter insertion.
Event or Problem Description
It was reported that the surgeon experienced difficulty inserting the anchor (superior patient left anchor).During insertion of the anchor into the cut track, it went into the device and locked into the implant, however it skived off the endplate and did not go into the vertebral body.The entire implant was then removed.Second attempt with a new implant same size; all 3 other anchors were inserted successfully.The superior anchor was left for last, surgeon had the same issue.Upon insertion of the anchor he could not get the anchor to advance all the way.He then removed the insertion guide and tried to freehand tamp the anchor and the anterior aspect of the device bent.3mm of the anchor was protruding anteriorly to of the device.Surgeon did not want to remove the entire device and therefore decided to use a metal cutting burr to grind away protruding anchor, leaving the majority of the anchor in the patient.All 3 other anchors went through easily, the patient's bone quality was very hard at the specific region where the 4th anchor would not go in.

• Brand Name: AERO AL LUMBAR CAGE 22 X 28MM, 11MM, 04 DEG.
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6018852
• Report Number: 3004024955-2016-00094
• Device Sequence Number: 902666
• Product Code: OVD
• UDI-Device Identifier: 07613327067613
• UDI-Public: (01)07613327067613
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133328
• 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): 09/14/2016

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 Catalogue Number: 48922214
• Device Lot Number: 145763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 68