MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	305008
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; i was alerted to a cage collapsing on (b)(6) 2017 from a case on (b)(6) 2017.
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.Method: device history review, complaint history review, risk assessment; result: the reported event of loss of height of the cage was confirmed based on provided x-ray images and medical records.Due to image quality the level of height reduction cannot be measured however from looking at the images the implant appears to reduce more than 1 mm in height.The implant appears to be placed well and snuggly fit, the supplemental fixation was used as indicated in the stg.Medical records were reviewed by a medical professional.The review indicated that the implant was used as indicated in the stg, no factors were identified that may have contributed to the implant not performing as intended.The patient is experiencing some back pain but it cannot be determined if pain is a result of implant reduction of height or due to patient's recovery from a surgery.Upon follow up it was confirmed that the construct looks stable.No intention to revise as of now.A manufacturing review of the device was performed and indicated no discrepancies or anomalies.Conclusion: the reported device remains implanted therefore a plausible root cause cannot be identified conclusively.
Event or Problem Description
It was reported that the cage reduced in height on (b)(6) 2017 from a case on (b)(6) 2017.

• Brand Name: ACCULIF TL 8-12 MM X 11MM X 34 MM X 0 DEG CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 6668453
• Report Number: 3004024955-2017-00026
• Device Sequence Number: 45516
• Product Code: MAX
• UDI-Device Identifier: 07613327068054
• UDI-Public: (01)07613327068054
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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 Expiration Date: 07/31/2017
• Device Model Number: 305008
• Device Catalogue Number: 305008
• Device Lot Number: 07201508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2017
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 04/24/2018
• 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
• Patient Age: 55 YR