LIF-PTP ACCESS SYSTEM
Received Jun 9, 2026 · Event occurred Jun 1, 2026
Report 2027467-2026-00131 · MDR key 25451223
Device
Generic name
Retractor
Manufacturer
Alphatec Spine, Inc.Model number
300-150-120Catalog number
300-150-120
Lot number
MM350253
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hematoma
- Hemorrhage/Blood Loss/Bleeding
Narrative
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.
Description of Event or Problem
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.