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

Model Number	73772
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the returned instrument (screw extender) found no manufacturing, processing or design related irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.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
An international customer ((b)(6)) reported a part of the wing is broken.

• 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: 7789886
• Report Number: 2027467-2018-00060
• Device Sequence Number: 19155228
• Product Code: LXH
• UDI-Device Identifier: 00840967192901
• UDI-Public: (01)00840967192901(10)7627804
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2018

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: No Information
• Device Model Number: 73772
• Device Catalogue Number: 73772
• Device Lot Number: 7627804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/16/2018
• 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