MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL 6-9MM X 11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	400006
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one year post op ct scan (original surgery date of 2015) shows cage at l4-5 still fully distracted.Cage at l5-s1 is completely collapsed.Patient is doing fine, evidence of bone growth, so surgeon will continue to follow patient.
Additional Manufacturer Narrative
Device history review, complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Based on the fatigue testing results, the surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact the performance of the intervertebral body fusion device.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G.Substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.Failure of the implant could not be confirmed conclusively therefore a plausible root cause could not be identified.
Event or Problem Description
It was reported that one year post op ct scan (original surgery date of 8-18-15) shows cage at l4-5 still fully distracted.Cage at l5-s1 is completely collapsed.Patient is doing fine, evidence of bone growth, so surgeon will continue to follow patient.

• Brand Name: ACCULIF PL 6-9MM X 11MM X 27 MM X 8 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5978372
• Report Number: 3004024955-2016-00087
• Device Sequence Number: 93060
• Product Code: MAX
• UDI-Device Identifier: 07613327066753
• UDI-Public: (01)07613327066753
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2016

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: 400006
• Device Lot Number: 02021510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2016
• Supplement Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1