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

Catalog Number 905103

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Torn Material (3024); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2016

Event Type  malfunction  

Event Description

It was reported that a tubing had a gash torn in it, and wouldn't expand, used it as a static cage.

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 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
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5485787
• MDR Text Key: 40031216
• Report Number: 3004024955-2016-00024
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327067064
• UDI-Public: 07613327067064
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 905103
• Device Lot Number: 08061502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1