MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48955106
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Injury (2348)
Date of Event	10/11/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the surgeon phoned to say his patient had suffered a fall 2 weeks postoperatively and as a consequence has leg pain.The surgeon reported that on x-ray the cages appears to have retro pulsed out of the disc space.The x-rays have not yet been viewed by the stryker representative.
Additional Manufacturer Narrative
Date of explant: (b)(6) 2016.Device history review, complaint history review, risk assessment; manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The plausible root cause of the reported event is due to the patient's fall.
Event or Problem Description
It was reported that; the surgeon phoned to say his patient had suffered a fall 2 weeks postoperatively and as a consequence has leg pain.The surgeon reported that on x-ray the cages appears to have retro pulsed out of the disc space.The x-rays have not yet been viewed by the stryker representative.
Additional Manufacturer Narrative
Device evaluation, device history review, complaint history review, risk assessment.After inspection, it's confirmed that no defects are found on the returned implant.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The plausible root cause of the reported event is due to the patient's fall.
Event or Problem Description
It was reported that; the surgeon phoned to say his patient had suffered a fall 2 weeks postoperatively and as a consequence has leg pain.The surgeon reported that on x-ray the cages appears to have retro pulsed out of the disc space.The x-rays have not yet been viewed by the stryker representative.

• Brand Name: 10MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6085169
• Report Number: 3004024955-2016-00099
• Device Sequence Number: 775509
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: (01)07613327118087
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48955106
• Device Lot Number: AAET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 01/13/2017; 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention