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	Muscle Weakness/Atrophy (1967)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unit has not returned for evaluation.The identifying serial number has not been provided.A root cause cannot be determined at this time.If additional information is received, a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2022, a patient had a postoperative deficit after undergoing a spinal procedure where a safeop unit was used.It was reported the patient had quadriceps weakness on the operative side.There was no allegation of product malfunction.

• 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: 14465333
• Report Number: 2027467-2022-00031
• Device Sequence Number: 11904491
• Product Code: GWF
• UDI-Device Identifier: 00190376330723
• UDI-Public: 00190376330723
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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
• 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: 04/21/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown