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

Catalog Number	905103
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tubing had a gash torn in it, and wouldn't expand, used it as a static cage.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.The reported complaint of main body leakage was confirmed via correspondence with the sales rep.Device is not returned.No relevant manufacturing issues were identified as all released units met stryker specifications.The device was not returned for evaluation and a plausible root cause for the leakage cannot be confirmed.
Event or Problem Description
It was reported that a tubing had a gash torn in it, and wouldn't expand, used it as a static cage.

• 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: 5485787
• Report Number: 3004024955-2016-00024
• Device Sequence Number: 10986711
• Product Code: MAX
• UDI-Device Identifier: 07613327067064
• UDI-Public: 07613327067064
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 02/11/2016

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: 08061502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 04/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1