NA 389.265Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034775203), received between Apr 18, 2017 and May 24, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE WAREHOUSE RECEIVED THE DEVICE AND DURING INSPECTION IT WAS IDENTIFIED THAT THE KEY WAS BROKEN. THIS REPORT INVOLVES ONE LAMINA SPREADER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487877 ↗
• MalfunctionJul 28, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LEAF SPRING HAD SNAPPED DURING INSPECTION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LAMINA SPREADER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238142 ↗
• MalfunctionMay 13, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON (B)(6) 2021, THE LAMINA SPREADER WAS DISCOVERED TO BE BROKEN DURING RECONFIGURATION OF A KIT IN STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LAMINA SPREADER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820966 ↗
• MalfunctionApr 18, 2017Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, DURING A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (TPLIF) WITH MATRIX SYSTEM AND MTF BONE IMPLANT, THE LAMINA SPREADER, WHICH WAS USED TO PERFORM THE DISCECTOMY AND DISTRACT THE WORKING AREA, WAS NOT HOLDING PROPERLY. THE SURGEON REQUESTED ANOTHER LAMINA SPREADER IN ORDER TO COMPLETE THE CASE. IT SEEMS LIKE THE HINGE DOES NOT HOLD AS WELL AS IT SHOULD. IN ADDITION, THE SURGEON WAS FINALIZING THE POSITION OF ONE (1) OF THE MATRIX SCREWS AND FOUND THAT THE T-HANDLE T25 STARDRIVE SHAFT FOR MATRIX-STANDARD WAS NOT WORKING PROPERLY. THE END OF THE DISTAL TIP OF THE SCREWDRIVER IS SLIGHTLY STRIPPED. NOTHING FELL INTO THE PATIENT. ANOTHER SAME/LIKE PRODUCT WAS USED. THERE WAS NO SURGICAL DELAY DURING THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. CONCOMITANT DEVICES REPORTED: MATRIX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6500385 ↗