KONG-TL VBR System, Screwdriver for Locking Screw 44-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640164847849), received between Oct 28, 2022 and Aug 21, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionAug 21, 2025Break; Break

  DURING THE LOAN CONTAINER INSPECTION AT THE MANUFACTURER IT WAS NOTICED THAT THE TIP OF A SCREWDRIVER WAS BROKEN OFF. IT IS ASSUMED THAT THE FRAGMENT HAS BROKEN OFF DURING THE LAST SURGERY. IT CAN NOT BE EXCLUDED THAT THE BROKEN OFF FRAGMENT REMAINED IN THE HEAD OF THE LOCKING SCREW AND THEREFORE IN THE PATIENT'S BODY. THE SUITABILITY OF THE MATERIAL OF THE FRAGMENT (STAINLESS STEEL 1.4112) HAS NOT BEEN EVALUATED FOR LONG-TERM TISSUE/BONE CONTACT. UNDESIRABLE LOCAL OR SYSTEMIC EFFECTS CANNOT BE EXCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860250 ↗
• InjuryJul 28, 2023Break; Break

  DURING A CORPECTOMY PROCEDURE AN EXPANDABLE ICOTEC VBR IMPLANT WAS IMPLANTED. FOLLOWING EXPANSION OF THE IMPLANT THE HEIGHT OF THE VBR WAS FIXED WITH THE LOCKING SCREW. THE SCREWDRIVER INTENDED FOR LOCKING MUST BE USED TOGETHER WITH THE RESPECTIVE TORQUE LIMITING HANDLE (1 NM). AFTER CHECKING THE IMPLANT POSITION THE SURGEON DECIDED TO READJUST THE POSITION OF THE VBR. WHEN TRYING TO LOOSEN THE SET SCREW, THE SURGEON NOTICED THAT THE SCREWDRIVER TIP HAD SHEARED OFF. THE SITUS WAS INSPECTED WITH IMAGING TOOLS BUT THE FRAGMENT WAS NOT FOUND. IT IS THEREFORE ASSUMED THAT THE FRAGMENT DID NOT REMAIN IN THE PATIENT. IT WAS NOT POSSIBLE TO READJUST THE POSITION OF THE VBR. THE SURGEON DECIDED TO LEAVE THE IMPLANT AS IT WAS AND TO COMPLETE THE SURGERY. DUE TO THE RESULT OF A FOLLOW-UP EXAMINATION (SUBOPTIMAL PLACEMENT OF THE VBR), THE SURGEON DECIDED TO REVISE THE IMPLANT. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411920 ↗
• MalfunctionMar 7, 2023Material Integrity Problem; Material Integrity Problem

  DURING A CORPECTOMY AN EXPANDABLE ICOTEC VBR IMPLANT WAS IMPLANTED. THE SET HEIGHT OF THE VBR IS FIXED WITH A LOCKING SCREW. WHEN TIGHTENING THE LOCKING SCREW, IT WAS NOTICED THAT THE SCREWDRIVER TIP HAD BROKEN OFF. THE BROKEN OFF FRAGMENT HAS STUCK IN THE HEAD OF THE LOCKING SCREW. THE VBR WAS LEFT IMPLANTED AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE BROKEN OFF FRAGMENT REMAINED IN THE SCREW HEAD AND THEREFORE IN THE PATIENT'S BODY. THE SUITABILITY OF THE MATERIAL OF THE FRAGMENT (STAINLESS STEEL 1.4112) HAS NOT BEEN EVALUATED FOR LONG-TERM TISSUE/BONE CONTACT. UNDESIRABLE LOCAL OR SYSTEMIC EFFECTS CANNOT BE EXCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495022 ↗
• MalfunctionOct 28, 2022Break; Break

  WHEN TIGHTENING THE LOCKING SCREW OF THE EXPANDABLE VBR, IT WAS NOTICED THAT THE SCREWDRIVER TIP HAD BROKEN OFF. THE BROKEN OFF FRAGMENT REMAINED IN THE HEAD OF THE LOCKING SCREW. THE VBR WAS LEFT IMPLANTED AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE BROKEN OFF FRAGMENT REMAINED IN THE SCREW HEAD AND THEREFORE IN THE PATIENT'S BODY. THE SUITABILITY OF THE MATERIAL OF THE FRAGMENT (STAINLESS STEEL 1.4112) HAS NOT BEEN EVALUATED FOR LONG-TERM TISSUE/BONE CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691054 ↗