MAUDE Adverse Event Report: ALPHATEC SPINE, INC. LIF-PTP ACCESS SYSTEM; RETRACTOR

Model Number	300-150-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/01/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The returned device was visually and functionally inspected, and no abnormalities or damage were identified.Review of the manufacturing records found no deviations or nonconformances.Based on available information, no device malfunction or manufacturing related issues was identified.Although the definitive cause of death has not been determined, the event may be associated with postoperative complications and the patient's underlying medical conditions.
Event or Problem Description
A patient underwent a spinal procedure at l3/4 using the lateral interbody fusion prone transposes (ptp) approach for adjacent segment disease on (b)(6) 2026.No intraoperative abnormalities were reported, and the immediate postoperative course was initially stable.Four days postoperatively, the patient experienced bleeding requiring transfusion, after which the patient stabilized.Two days later, radiographic imaging identified a hematoma near the segmental artery near the l3/4 level on the left approach side.Later that evening, the patient's condition deteriorated, including development of a psoas muscle hematoma followed by non-occlusive mesenteric ischemia (nomi), which was triggered by hemorrhagic shock.The patient subsequently expired.

• Brand Name: LIF-PTP ACCESS SYSTEM
• Common Device Name: RETRACTOR
• 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: 25451223
• Report Number: 2027467-2026-00131
• Device Sequence Number: 18310261
• Product Code: GAD
• UDI-Device Identifier: 00190376307015
• UDI-Public: (01)00190376307015(10)MM350253
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: 300-150-120
• Device Catalogue Number: 300-150-120
• Device Lot Number: MM350253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown