MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TT STRAIGHT IMPLANT HOLDER

Catalog Number	4200-1001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the subject device.The review revealed there were no issues during the manufacture of the lot of the subject device that would contribute to this complaint condition.The lot of the subject device conformed and passed the inspection record.The subject device was evaluated and confirmed the distal tip of the threaded holder had sheared off.Wear due to fatigue caused by the age of the instrument is the likely cause of the threaded tip shearing off the instrument during use.Attempts have been made to have the surgeon provide a statement that the tip of the threaded holder remaining implanted will not have an adverse effect on the patient.If surgeon provides a statement, a follow up report will be submitted.
Event or Problem Description
During a tlif t5 spinal fusion case, the surgeon had the tip of a tt implant holder shear off while attempting to place the implant.The tip of the threaded holder remained attached to the implant.The surgeon determined the implant was in the proper positon within the disk space.The surgeon finished the procedure with no further issues.Follow up x-rays confirmed the placement of the implant within the disk space.There were no adverse effects or injury to the patient as a result of the tt implant holder failure.
Additional Manufacturer Narrative
A review of the device history records was performed for the subject device.The review revealed there were no issues during the manufacture of the lot of the subject device that would contribute to this complaint condition.The lot of the subject device conformed and passed the inspection record.The subject device was evaluated and confirmed the distal tip of the threaded holder had sheared off.Attempts have been made to have the surgeon provide a statement that the tip of the threaded holder remaining implanted will not have an adverse effect on the patient.If surgeon provides a statement, a follow up report will be submitted.
Event or Problem Description
During a tlif t5 spinal fusion case, the surgeon had the tip of a tt implant holder shear off while attempting to place the implant.The tip of the threaded holder remained attached to the implant.The surgeon determined the implant was in the proper positon within the disk space.The surgeon finished the procedure with no further issues.Follow up x-rays confirmed the placement of the implant within the disk space.There were no adverse effects or injury to the patient as a result of the tt implant holder failure.

• Brand Name: ENDOSKELETON® TT STRAIGHT IMPLANT HOLDER
• Common Device Name: IMPLANT HOLDER
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 5632762
• Report Number: 3006340236-2016-00002
• Device Sequence Number: 16205724
• Product Code: LXH
• UDI-Device Identifier: M682420010010
• UDI-Public: +M682420010010/$R110110P
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K083714
• 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): 04/18/2016

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: Physician
• Device Catalogue Number: 4200-1001
• Device Lot Number: R110110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1