MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TO; 0 DEG LORDOTIC, IMPLANT, 26X14MM, PLIF

Model Number	3114-2614
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Titan spine requested a subject matter expert (sme) to review the post-op fluoroscopy films that were provided from the intial surgery.The sme reviewed the films and spoke with the surgeon.The sme concluded "the fracture is most likely do to stress risers secondary to insertion of an implant that was too large for the disc space and not recessed adequately." a review of the device history record for the subject device was performed.The review revealed no anomalies or non-conformances were generated during the manufacture of the device that would contribute to this complaint condition.The device was found to be within specification during inspection.Device not returned to manufacturer.
Event or Problem Description
An l4/5 tlif procedure occurred on (b)(6) 2016 implanting an endoskeleton® to 0 deg lordotic, implant, 26x14mm, plif.Approximately two week later, the patient describes hearing a "pop" in her back.Patient had l5 vertebral fracture.Patient was scheduled for revision surgery, cage was removed, patient was re-instrumented with pedicle screws.There was no adverse effects or injury to the patient as a result.The explanted device was kept at (b)(6).Patient is a female, (b)(6), non-smoker.Patient did not fall.Patient does not have prior fusions at levels that were being treated.Patient was given post-operative instructions.

• Brand Name: ENDOSKELETON® TO
• Common Device Name: 0 DEG LORDOTIC, IMPLANT, 26X14MM, PLIF
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6358584
• Report Number: 3006340236-2017-00001
• Device Sequence Number: 16329752
• Product Code: MAX
• UDI-Device Identifier: 00191375004769
• UDI-Public: (01)00191375004769(11)130301(10)A130345(240)31142614
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K102067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 3114-2614
• Device Catalogue Number: 3114-2614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Weight: 88