MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO-LL LUMBAR CAGE SYSTEM 8X45MMX0DEG - 18; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48940108
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hard bone caused the post connecting rail of the device to break and upon further impaction the cage curled up and pushed the cage out of the disc space.Update: at this stage, patient seems to be fine with no revision surgery scheduled.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: since the reported device is still implanted in the patient, the root cause could not be determined conclusively.
Event or Problem Description
It was reported that the hard bone caused the post connecting rail of the device to break and upon further impaction, the cage curled up and pushed the cage out of the disc space.Picture attached and waiting to possibly revise with an alif.Update: at this stage, patient seems to be fine with no revision surgery scheduled.

• Brand Name: AERO-LL LUMBAR CAGE SYSTEM 8X45MMX0DEG - 18
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5621078
• Report Number: 0009617544-2016-00169
• Device Sequence Number: 237385
• Product Code: MAX
• UDI-Device Identifier: 07613327065695
• UDI-Public: (01)07613327065695
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 04/05/2016

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: 48940108
• Device Lot Number: 14G479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• Supplement Report FDA Received Date: 07/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1