MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TCS IMPLANT; INTERBODY FUSION DEVICE CERVICAL

Catalog Number 5366-1408

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

During the procedure when the surgeon was installing the inferior tcs bone screw, the bone screw did not follow the pilot hole created by the bone awl.Instead the screw formed its own trajectory into the bone.The trajectory of the bone screw was poor, leading to a jackknife position of the implant within the disc space.The surgeon decided to explant the implant.Rep believes the wrong size implant was chosen by the surgeon.The returned implant was examined and found to be within specification.Device history records indicate implant meet spec prior to being released to the field.

Event Description

During a stand alone cervical case, the tcs implant rotated in the interbody space.It is believed the screw failed.The tcs implant and the screws were explanted.The caudal screw was a task to remove during the explantation.No injury or adverse effect came to the patient as a result of the malfunction.

• Brand Name: ENDOSKELETON TCS IMPLANT
• Type of Device: INTERBODY FUSION DEVICE CERVICAL
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• Manufacturer Contact: jane rodd ; 6140 w. executive dr. ste a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 5318520
• MDR Text Key: 34918605
• Report Number: 3006340236-2015-00013
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• PMA/PMN Number: K142940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5366-1408
• Device Lot Number: A150427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2015
• 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