MAUDE Adverse Event Report: ALPHATEC SPINE, INC. LATERAL PATIENT POSITIONING SYSTEM; SUPPORT, PATIENT POSITION

Model Number	181-100
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device did not return for evaluation.Photographs were not provided; therefore, the complaint cannot be confirmed.A review of device history records showed no manufacturing or processing related irregularities.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Postoperatively, internal bleeding was noted under the patient's right axilla.The attending nurse confirmed that there was no evidence of this bleeding prior to the operation and indicated that it was most likely associated with the use of the positioner.Following the surgery, the patient reported no pain related to this incident.

• Brand Name: LATERAL PATIENT POSITIONING SYSTEM
• Common Device Name: SUPPORT, PATIENT POSITION
• 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: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 21894986
• Report Number: 2027467-2025-00061
• Device Sequence Number: 3530885
• Product Code: CCX
• UDI-Device Identifier: 00190376484112
• UDI-Public: (01)00190376484112(10)EM53802
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 181-100
• Device Catalogue Number: 181-100
• Device Lot Number: EM53802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male