FDA Adverse Event
Malfunction
Summary report: N
KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW
MDR report key: 16495022
·
Received March 7, 2023
Report
- Report Number
- 3006493760-2023-00001
- Event Type
- Malfunction
- Date Received
- March 7, 2023
- Date of Event
- January 30, 2023
- Report Date
- March 7, 2023
- Manufacturer
- ICOTEC AG
- Product Code
- MQP
- UDI-DI
- 07640164847849
- PMA / PMN Number
- K200235
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140542 | KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW | Spinal vertebral body replacement device | MQP | ICOTEC AG | 44-050 | 20/02 | 07640164847849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |