MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SE REDUCER (STAINLESS STEEL); LXH

Model Number	73734
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The instruments have not been returned for evaluation nor has the identifying lot number(s) been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
During a difficult multi-level spondy reduction, two towers broke while under reductions and two more broke during removal/detachment from the screw.The patient was reported to have usually hard dense bone which forced the surgeon to drill 6 of 8 pedicles.During reduction, the strain on the instruments popping & cracking could be heard.The event caused a two hour delay in the case.

• Brand Name: SE REDUCER (STAINLESS STEEL)
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8212517
• Report Number: 2027467-2018-00088
• Device Sequence Number: 1900681
• Product Code: LXH
• UDI-Device Identifier: 00844856041721
• UDI-Public: (01)00844856041721
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: Health Professional
• Device Model Number: 73734
• Device Catalogue Number: 73734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/03/2019
• 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: Hospitalization