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

Model Number	73724
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The international customer returned a second screw extender.It is of the same manufacturing lot number as reported.An evaluation of the returned instruments (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 that the side clip of the screw extender had fractured.In this case, the surgeon had used the screw extender alignment guide to attach the extenders to the implants.The surgeon also had used the screw extender remover tool to detach the screw extender at the end of the surgery, but the extender still was damaged.

• Brand Name: SCREW EXTENDER (STAINLESS STEEL)
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5663266
• Report Number: 2027467-2016-00032
• Device Sequence Number: 88423
• Product Code: LXH
• UDI-Device Identifier: 00844856041691
• UDI-Public: 00844856041691
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2016

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: 73724
• Device Catalogue Number: 73724
• Device Lot Number: 6811701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2016
• Initial Report FDA Received Date: 05/18/2016
• 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: Congenital Anomaly
• Patient Age: 70 YR