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

Model Number	AIX11901
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit returned to alphatec and case logs were reviewed.It was determined the response does not appear to be coming from the safeop system as it did not occur at regular intervals, and it does not match the intensity or shape normally seen from a temg response.In addition, it does not appear to be a physiological issue, as the waveform observed in the left biceps femoris were extremely consistent throughout the case.The root cause of this artifact is likely a result of another electro monitoring system that may have been attached to the patient.
Event or Problem Description
It was reported during a case involving a safeop unit low temg thresholds occurred across multiple surgical levels.The surgeon aborted the case.It is unknown if the low values were artifact.The sales rep is confident the bovie pad wasn't near leads and that stim return as well as ground were in correct locations.

• Brand Name: SAFEOP
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vide roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vide roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 15852591
• Report Number: 2027467-2022-00084
• Device Sequence Number: 15065416
• Product Code: GWF
• UDI-Device Identifier: 00190376330723
• UDI-Public: (01)00190376330723
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/25/2022

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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