MAUDE Adverse Event Report: ALPHATEC SPINE INC BATTALION LXHLATERAL SPINAL SPACER SYSTEM

Model Number	27428
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned.
Event or Problem Description
Retractor arm button would not release from retractor.The event caused just over a 30 minute delay in the case.

• Brand Name: BATTALION LXHLATERAL SPINAL SPACER SYSTEM
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10737511
• Report Number: 2027467-2020-00045
• Device Sequence Number: 3335782
• Product Code: LXH
• UDI-Device Identifier: 00840967129136
• UDI-Public: (01)00840967129136
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: 27428
• Device Catalogue Number: 27428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/26/2020
• 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