FDA Adverse Event Injury Summary report: N

VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 5.5 × 40 MM

MDR report key: 20952490 · Received December 17, 2024

Report

Report Number: 3006493760-2024-00005
Event Type: Injury
Date Received: December 17, 2024
Date of Event: November 15, 2024
Report Date: December 17, 2024
Manufacturer: ICOTEC AG
Product Code: NKB
PMA / PMN Number: K232628
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

DATA RELATING TO MANUFACTURING DATE IS NOT ON THE LABEL AS PI. ANALYSIS OF THE RELEVANT PRODUCTION RECORDS OF THE PEDICLE SCREWS DID NOT IDENTIFY ANY ANOMALIES THAT COULD BE A CAUSE OF THE EVENT. INVESTIGATION OF HISTORICAL ADVERSE EVENT DATA DETERMINED THAT ICOTEC HAS BECOME AWARE OF ONE SIMILAR EVENT WITH THIS DEVICES BASED ON THE RISK TO TREAT FURTHER LEVELS TO DATE. THE EVALUATION OF THE RETURNED PEDICLE SCREWS DID NOT LEAD TO A CLEAR CONCLUSION OF THE ROOT CAUSE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION OF THE CAUSE OF THIS EVENT. BASED ON THE INFORMATION AVAILABLE, NO CORRECTIVE ACTIONS ARE PROPOSED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

A PATIENT IN SWITZERLAND WAS TREATED WITH 8 PEDICLE SCREWS T2/T3 AND T5/T6. DURING SCREW INSERTION ONE OF THE SCREWS IN T5 BROKE. THE PHYSICIAN THEN DECIDED TO TREAT ANOTHER LEVEL T7. ONE OF THE SCREWS IN T7 BROKE AS WELL DURING INSERTION AND THE PHYSICIAN TREATED ANOTHER LEVEL T8 WITH TITANIUM SCREWS. THE SURGERY WAS COMPLETED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
266246	VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 5.5 × 40 MM	VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 5.5 × 40 MM	NKB	ICOTEC AG	16-6022-55540	24/05

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Disability