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	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the returned instrument 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.A previous investigation found that the failure mode observed in this type of event, is 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
Both tabs of the screw extender were broken during the surgery.The surgeon heard a click when inserting the reducer but continued inserting the set screw.Then driver could not go in depth and the surgeon tried extending the item outward, but something was interfering.When removing the screw extender after final tightening, the tabs were found broken.All broken fragments were retrieved and no residual parts remain in the patient's body.

• 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: 9109654
• Report Number: 2027467-2019-00048
• Device Sequence Number: 10902820
• Product Code: LXH
• UDI-Device Identifier: 00840967192901
• UDI-Public: (01)00840967192901(10)6799802
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/13/2019

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: Health Professional
• Device Model Number: 73772
• Device Catalogue Number: 73772
• Device Lot Number: 6799802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/24/2019
• 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