MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48824014
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon the patient's follow up visit, it was discovered that the implants had started to detach off of the vertebrae.It is unknown at this time if the patient will undergo revision.
Additional Manufacturer Narrative
Method: x-ray review, labelling review, risk assessment.Result: the reported event was confirmed by the rep.Device was not returned and lot number not provided, therefore device evaluation, device history review, complaint history review could not be performed.X-ray review identifies two screws from the upper level of the plate backing out of the vertebrae but are still locked into the plate.No issue found on the plate itself.The surgical technique states that based on the fatigue testing results, the physician/ surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact on the performance of the system.Physician instructions regarding full weight-bearing activities must be complied with until maturation of the fusion mass is confirmed.Failure to comply with physician instructions may result in failure of the implant, the fusion, or both.Conclusion: the potential root causes of the reported event are the patient applies too much force an excessive number of times causing plates to be displaced, poor surgical candidate or bone quality, excessive post-op activity by patient (not recommended by surgeon), patient does not follow surgeon instructions, patient over exerts.However, the exact root cause could not be determined conclusively.
Event or Problem Description
It was reported that upon the patient's follow up visit, it was discovered that the implants had started to detach off of the vertebrae.It is unknown at this time if the patient will undergo revision.

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7898538
• Report Number: 0009617544-2018-00229
• Device Sequence Number: 1654397
• Product Code: KWQ
• UDI-Device Identifier: 07613252152606
• UDI-Public: 07613252152606
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 48824014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/27/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1