MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL TUBING SET; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	905103
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the implant failed to expand in situ.Surgeon stated that there was no hydraulic pressure when turning the plunger clockwise.We then had the surgeon fill up the plunger with water and additional time, it was still reported by the surgeon that there was no pressure when plunger was turned clockwise.We proceeded to change out both red and green washer with replacement red and green washers.There was still no hydraulic pressure reported.
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.Sales rep confirmed that the peek portion of the tube is cut near the distal tip.Due to this cut, the device cannot hold pressure while attempting to expand the implant.It was reported that the tech experienced difficulty with attaching the tubing set to the distal end of the inserter and he was manipulating the tubing to get it on properly.Conclusion: the root cause of the tubing set fracture is likely user related.
Event or Problem Description
It was reported that; the implant failed to expand in situ.Surgeon stated that there was no hydraulic pressure when turning the plunger clockwise.We then had the surgeon fill up the plunger with water and additional time, it was still reported by the surgeon that there was no pressure when plunger was turned clockwise we proceeded to change out both red and green washer with replacement red and green washers.There was still no hydraulic pressure reported.

• Brand Name: ACCULIF TL TUBING SET
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5514932
• Report Number: 3004024955-2016-00031
• Device Sequence Number: 13519439
• Product Code: MAX
• UDI-Device Identifier: 07613327067064
• UDI-Public: (01)07613327067064
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2016

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: 905103
• Device Lot Number: 09281506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 05/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1