MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON® TCS; BONE SCREW

Catalog Number 5301-3816

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The subject devices were discarded in surgery so no device evaluation occured.The dhr for the device was reviewed and the product was found conforming upon release.It was reported that the screws were discarded due to malfunctions while the screws were being inserted.The first screw was reported to have bent, and the second and third screw spun and sheared upon contacting the cage.The angle of screw insertion was difficult to match due to patient anatomy.The screws were determined to likely have bound against the cage causing partial delamination of the threads.Over the course of the investigation, it was identified that the surgeon was using "straight" (non-jointed, no angle) instrumentation, which would likely be used when there are no interfering anatomical features and access to the disc space is uninhibited.Additionally, it was identified that there were some anatomical barriers to overcome along with the screws potentially not following the awled trajectory.Therefore, the root cause was identified to have been that the appropriate surgical technique was not followed, which caused the functional issue with the screws.The issue was able to be resolved at the procedure by making use of additional tools within the tcs instrument set including a bone awl of a larger diameter and an angled screw driver to account for effect of the patient's anatomy on the insertion of the screw.

Event Description

The complainant alleged that three screws were attempted to be implanted and malfunctioned due to the angle of screw insertion being difficult to match based on patient anatomy.

• Brand Name: ENDOSKELETON® TCS
• Type of Device: BONE SCREW
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr.; suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE; 6140 w. executive dr.; suite a; mequon WI 53092
• Manufacturer Contact: quinn lyster ; 6140 w. executive dr.; suite a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 8541982
• MDR Text Key: 145634704
• Report Number: 3006340236-2019-00005
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5301-3816
• Device Lot Number: V08
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR