MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF PL 8-12MM X 11MM X 27 MM X 8 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	400008
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stryker spine sent an "urgent recall letter and product accountability form" dated july 26, 2016 to all affected customers.For patients who have had an acculif posterior lumbar (pl) expandable interbody implant, stryker spine is recommending routine clinical and radiographic post-operated evaluation.Should the patient report any change in or develop near-onset symptoms, more urgent clinical and radiographic evaluation should be completed.The patient received recall information from their surgeon.
Event or Problem Description
It was reported that a patient underwent a revision surgery in (b)(6) 2017 due to a migrated implant.The patient is experiencing pain in the abdominal area and in low back.
Additional Manufacturer Narrative
Result: visual, dimensional, functional and material analysis could not be performed as the device was not returned.X-rays, medical records and clinical history of the patient were not provided for evaluation.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.There were no previous similar complaints for the reported lot.No further investigation can be performed at this time based on the information provided.The cause of the reported event could not be determined.
Event or Problem Description
It was reported that a patient underwent a revision surgery in (b)(6) of 2017 due to a migrated implant.The patient is experiencing pain in the abdominal area and in low back.

• Brand Name: ACCULIF PL 8-12MM 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: 7296375
• Report Number: 3004024955-2018-00006
• Device Sequence Number: 1801456
• Product Code: MAX
• UDI-Device Identifier: 07613327066760
• UDI-Public: (01)07613327066760
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 400008
• Device Catalogue Number: 400008
• Device Lot Number: 05181510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2786-2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention