MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 0DEG X 9MM X 23MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48950100
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; surgeon texted me x-ray on (b)(6) 2017 of patient implant site at 6 week post-op visit showing an expulsed cage at l3/l4.Patient is currently asymptomatic.He notified me that he had scheduled her for revision/removal on (b)(6) 2017.Date of original surgery was (b)(6) 2017.Update 5/17/2017: patient received revision surgery on (b)(6) 2017.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.No defects were found on the returned implant conclusion: the plausible root cause of the reported event is likely due to events like the patient's fall.
Event or Problem Description
It was reported that; surgeon texted me x-ray on (b)(6) 2017 of patient implant site at 6 week post-op visit showing an expulsed cage at l3/l4.Patient is currently asymptomatic.He notified me that he had scheduled her for revision/removal on (b)(6) 2017.Date of original surgery was (b)(6) 2017.Update 5/17/2017: patient received revision surgery on (b)(6) 2017.

• Brand Name: 10MM X 0DEG X 9MM X 23MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6595236
• Report Number: 3004024955-2017-00022
• Device Sequence Number: 739137
• Product Code: MAX
• UDI-Device Identifier: 07613327117295
• UDI-Public: (01)07613327117295
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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 Model Number: 48950100
• Device Catalogue Number: 48950100
• Device Lot Number: AKN9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 74