AEGIS 287110550Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034218298), received between Jun 17, 2019 and Apr 5, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON MARCH 1, 2023 THAT THE SCREW DRIVERS ON AEGIS STRIPPED DURING SCREW INSERTION. THE SURGERY WAS DELAYED FOR 3 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AEGIS MODULAR SCREWDRIVER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683044 ↗
• MalfunctionApr 5, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023 THAT THE SCREW DRIVERS ON AEGIS STRIPPED DURING SCREW INSERTION. THE SURGERY WAS DELAYED FOR 3 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AEGIS MODULAR SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683036 ↗
• MalfunctionNov 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022,THAT AEGIS MODULAR SCREWDRIVER WARPED DUE TO SCLEROTIC BONE. THERE WAS NO ADVERSE EVENT TO THE PATIENT AND ONLY A 30 SECOND DELAY IN SURGERY THE SECOND SCREWDRIVER WAS USED WHICH ALSO WARPED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) AEGIS MODULAR SCREWDRIVER THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815709 ↗
• MalfunctionNov 17, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6 2022,THAT AEGIS MODULAR SCREWDRIVER WARPED DUE TO SCLEROTIC BONE THERE WAS NO ADVERSE EVENT TO THE PATIENT AND ONLY A 30 SECOND DELAY IN SURGERY THE SECOND SCREWDRIVER WAS USED WHICH ALSO WARPED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) AEGIS MODULAR SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815687 ↗
• MalfunctionJan 12, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SCREWDRIVERS STRIPPED. THE SURGERY WAS COMPLETED WITH THE SKYLINE X15 DRIVER THAT WAS IN THE SET. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) AEGIS MODULAR SCREWDRIVER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239510 ↗
• MalfunctionJan 12, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SCREWDRIVERS STRIPPED. THE SURGERY WAS COMPLETED WITH THE SKYLINE X15 DRIVER THAT WAS IN THE SET. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) AEGIS MODULAR SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239499 ↗
• MalfunctionJun 17, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019, PRIOR TO THE ANTERIOR LUMBAR INTERBODY FUSION (ALIF) L4-L5 PROCEDURE, THE MODULAR SCREWDRIVER FROM THE SET CALLED AEGIS WAS BURRED AT THE END, THE INSTRUMENT WAS NOT USED AS THERE WERE TWO ON THE SET. THIS WAS NOTED BEFORE THE CASE THAT THE AEGIS DID NOT RETAIN TO THE UNKNOWN SCREW, IT WAS FALLING OFF. ANOTHER SCREWDRIVER FROM THE ATB PLATE SYSTEM OF ANOTHER OPCO WAS ALSO MADE MENTION. IT WAS NOT LOCKING OFF AND HAS NO CLEAR CLICK SOUND WHEN LOCKING THE SCREWS. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705333 ↗