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

Model Number	64920
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event has not been provided and is unknown.Review of the device history records revealed no manufacturing, processing or design related irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.An evaluation of the returned novel inserter revealed the inner shaft had fractured and broke at the threaded distal tip.The fracture is flush with the distal tip of the inserter tube, which houses the inner shaft.A previous investigation for this type of event found that an excessive lateral load was placed on the titanium trial which caused the threaded tip to shear along the distal tip of the inserter tube.
Event or Problem Description
The tip of a novel inserter was discovered broken during a routine inspection.

• Brand Name: NOVEL LUMBAR INSERTER ASSEMBLY (STAINLESS STEEL)
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5787248
• Report Number: 2027467-2016-00045
• Device Sequence Number: 1456911
• Product Code: LXH
• UDI-Device Identifier: 00844856034884
• UDI-Public: 00844856034884
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 06/14/2016

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 Model Number: 64920
• Device Catalogue Number: 64920
• Device Lot Number: 6820702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2016
• Initial Report FDA Received Date: 07/12/2016
• 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