MAUDE Adverse Event Report: ALPHATEC SPINE INC BATTALION, LLIF TABLE FIXATION ARM, (STAINLESS STEEL); HXC

Model Number	27428
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The case was rescheduled for march 18, 2019.Atec manager, product development was present & discovered the user facility's spd department was responsible for the incident.The operating surgeon explained that during cleaning/sterilization, hospital personnel disassembled the docking arm/locking mechanism and did not reassemble it.The set was wrapped and forwarded to the or for use.Once the case began, the docking arm was found disassembled.
Event or Problem Description
While starting the lateral procedure, attempted to place retractor and noted on the back table that the docking arm/locking mechanism on retractor arm had disassembled and could not be reassembled.The gold button on the table fixation arm was not functioning.Patient was on the table with an incision and dilators placed.Surgery had to be rescheduled.The event caused over a 30 minute delay in the case.

• Brand Name: BATTALION, LLIF TABLE FIXATION ARM, (STAINLESS STEEL)
• Common Device Name: HXC
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8499649
• Report Number: 2027467-2019-00014
• Device Sequence Number: 13935155
• Product Code: HXC
• UDI-Device Identifier: 00840967129136
• UDI-Public: (01)00840967129136(10)7981101S1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/13/2019

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
• Device Lot Number: 7981101S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/10/2019
• 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
• Patient Age: 65 YR