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

Catalog Number 905103

Device Problems Fracture (1260); Material Frayed (1262); Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 11/17/2015

Event Type  malfunction  

Event Description

It was reported that; frayed tubing set at point of implant juncture.Had to replace tubing set with a new one.

Manufacturer Narrative

Visual inspection; device history review; complaint history review; risk assessment the returned was confirmed to be fractured near the distal end of tubing set upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.The most likely cause is likely multifactorial in nature, it is unknown during when the damage occurred.

Event Description

It was reported that; frayed tubing set at point of implant juncture.Had to replace tubing set with a new one.

• 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: 5298965
• MDR Text Key: 34252563
• Report Number: 3004024955-2015-00111
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143616
• 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: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• 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: 05201512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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