MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TT; THIN, PUSHER

Model Number	4200-1021
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the product device history record for the subject device was completed.Review revealed there were no anomalies or nonconformance's generated during the manufacture of the devices that would have led to this complaint condition.The devices passed inspection and were approved for initial use.An engineering design change is being completed to update the design of the endoskeleton® tt thin pusher by thickening the tip in order to improve the mechanical durability of the instrument.This change is only an improvement and will not affect fit, form or function as the endoskeleton® tt instrument positioning tool.The update design was validated.The report concluded the endoskeleton® tt thin pusher improved the mechanical durability of the instrument without impacting fit, form or function of the instrument.
Event or Problem Description
During a l4-l5 tlif procedure, the surgeon was tapping the thin pusher with a mallet when the tip broke.The tip was easily and promptly removed.The case continued and completed with no delay, adverse effects or injury to the patient.
Event or Problem Description
During a l4-l5 tlif procedure, the surgeon was tapping the thin pusher with a mallet when the tip broke.The tip was easily and promptly removed.The case continued and completed with no delay, adverse effects or injury to the patient.
Additional Manufacturer Narrative
A review of the product device history record for the subject device was completed.Review revealed there were no anomalies or nonconformance's generated during the manufacture of the devices that would have led to this complaint condition.The devices passed inspection and were approved for initial use.

• Brand Name: ENDOSKELETON® TT
• Common Device Name: THIN, PUSHER
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6487253
• Report Number: 3006340236-2017-00007
• Device Sequence Number: 1201670
• Product Code: LXH
• UDI-Device Identifier: 00191375003014
• UDI-Public: (01)00191375003014(10)UU160311(240)42001021
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/19/2018

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 Model Number: 4200-1021
• Device Catalogue Number: 4200-1021
• Device Lot Number: UU160301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1