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

Model Number	AIX11901
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a case, the standard needle set up was completed.When the leads were plugged into the unit, the ground electrode was not registering in the electrode test.The needle and harness were replaced with no change.Another unit was used to complete the case.This resulted in a delay in surgery.
Additional Manufacturer Narrative
The unit returned for evaluation.Visual inspection was performed and did not identify any irregularities.The unit passed functional testing.The reported issue could not be duplicated nor confirmed.Review of the device history record indicates the unit conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.The root cause could not be determined.

• Brand Name: SAFEOP
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): 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: 18509535
• Report Number: 2027467-2023-00095
• Device Sequence Number: 20786289
• Product Code: GWF
• UDI-Device Identifier: 00190376330723
• UDI-Public: (01)00190376330723(10)CX18413
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: AIX11901
• Device Catalogue Number: AIX11901
• Device Lot Number: CX18413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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 Age: 57 YR
• Patient Sex: Female