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

Model Number 27428

Device Problem Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

No evaluation possible at this time.The instrument has not been returned.

Event 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
• Type of Device: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604949286
• MDR Report Key: 10737511
• MDR Text Key: 213251896
• Report Number: 2027467-2020-00045
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00840967129136
• UDI-Public: (01)00840967129136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27428
• Device Catalogue Number: 27428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization