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

Catalog Number 48922214

Device Problems Bent (1059); Difficult to Insert (1316); Material Deformation (2976); Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2016

Event Type  malfunction  

Event 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.Three mm 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.

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 patient's very hard bone; over impaction during the pilot cutter insertion.

Event 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.
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6018851
• MDR Text Key: 57465156
• Report Number: 3004024955-2016-00095
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07613327067613
• UDI-Public: (01)07613327067613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48922214
• Device Lot Number: 145764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 68