MAUDE Adverse Event Report: ALPHATEC SPINE INC REDUCTION SCREW EXTENDER (STAINLESS STEEL); LXH

Model Number	73772
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two separate identifying lot numbers were returned for evaluation.Both are of the same product model part number/description.An evaluation of both returned instruments revealed no manufacturing or processing related irregularities.The instruments were found to be properly manufactured and released in accordance with design specifications.Device# 1 (6674401s3) - inspection found the distal functioning section of the device which mates with the polyaxial screw has been bent/deformed.The corresponding halves of the open distal end are no longer cylindrical which is causing the mating tabs not properly locate with the polyaxial screw.Additionally, the tip has fractured and cracked at the.145 tab slot and continues distally until it breaks thru at the.225 rod channel.This type of deforming/bending is consistent with the attempted release of the instrument from the mating polyaxial screw when the alignment guide is not utilized.Device# 2 (6799802, manufactured 8/8/2013) - visual inspection revealed that one of the dimples ((b)(4)) had been completely removed/broken from the instrument.Although the device was properly manufactured additional investigation was conducted to determine root cause.The analysis showed that the failure mode observed in this event was due to imparting excessive torsional loads to the mating instrument (reducer) during the rod reduction maneuver.Excessive load can be applied due to a tolerance gap condition between the reducer and extenders.The over-torque observation was corroborated by the two design interface analyses (dias) that were performed on the reducer/screw extender interfaces.
Event or Problem Description
While reducing the rod, the sleeve of the extender snapped.The surgeon wanted to final tighten the other screws so he remove the extender sleeve giving him more room to reattach the sleeve that broke loose.The event caused over a 30 minute delay in the case.

• Brand Name: REDUCTION SCREW EXTENDER (STAINLESS STEEL)
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5822979
• Report Number: 2027467-2016-00055
• Device Sequence Number: 346319
• Product Code: LXH
• UDI-Device Identifier: 00840967192901
• UDI-Public: 00840967192901
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/11/2016

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: 73772
• Device Catalogue Number: 73772
• Device Lot Number: 6674401S3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2016
• Initial Report FDA Received Date: 07/26/2016
• 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; Required Intervention
• Patient Age: 69 YR