MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SAFEOP; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	AIX11901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Twitching (2172)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The safeop unit returned to alphatec on 10/18/2022.Case logs were pulled and reviewed by the safeop engineering team.The system tried to end impedance test but started polling old electrode test repeatedly and calling the proceed button to appear.The case logs indicate the wi-fi connection dropped just before the table went into this error state.It is unknown if this correlated with the incident.The issue could not be duplicated during in-house testing of the unit.The root cause could not be determined.
Event or Problem Description
It was reported a patient underwent a single level l4-l5 lif procedure which involved a safeop unit.After the emg electrodes were connected there was spontaneous stimulating to the patient without any triggered emg being activated.The headbox to the unit was turned on and off multiple times.There was a rhythmic twitch in the patient's foot when the machine was on, but without the input of any triggered emg or ssep stimulus.This same twitch was not present when the headbox power was turned off.The surgeon aborted the case due to this incident.

• Brand Name: SAFEOP
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 15810419
• Report Number: 2027467-2022-00087
• Device Sequence Number: 5747190
• Product Code: GWF
• UDI-Device Identifier: 00190376330723
• UDI-Public: (01)00190376330723
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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
• Device Model Number: AIX11901
• Device Catalogue Number: AIX11901
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown