MAUDE Adverse Event Report: ALPHATEC SPINE INC NOVEL POSTERIOR INSERTER STRAIGHT ASSEMBLY (STAINLESS STEEL); LXH

Model Number	64918
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inspection of the inserter (64918) revealed that the 6-32 threads of the internal shaft had fractured and broke at the distal tip of the instrument.The fracture is flush with the inserter tube which houses the inner shaft.The implant retriever (64641) which also fractured while attempting to the retrieve the detached section of the inserter was manufactured on october 1, 2014 (lot# 7178102).Visual inspection found that the top jaw had fractured and broke at the.079/.082 top thru hole (pivot location).An evaluation of both returned instruments and review of the corresponding device history records found no manufacturing, processing or design related irregularities.The instruments were found to be properly manufactured and released in accordance with the device master record.
Event or Problem Description
The threaded part of the inserter that threads into the peek implant sheared off inside the implant during insertion.While trying to retrieve the implant, part of the implant retriever broke inside of the patient.There was about a 30 minute delay in the case from the time the first instrument broke, to the time the cage was successfully placed.

• Brand Name: NOVEL POSTERIOR INSERTER STRAIGHT ASSEMBLY (STAINLESS STEEL)
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6132847
• Report Number: 2027467-2016-00093
• Device Sequence Number: 10878920
• Product Code: LXH
• UDI-Device Identifier: 00844856041271
• UDI-Public: 00844856041271
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 10/21/2016

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: 64918
• Device Catalogue Number: 64918
• Device Lot Number: 5848901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/29/2016
• 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: Other
• Patient Age: 63 YR