FDA Adverse Event Injury Summary report: N

VADER PEDICLE SYSTEM, S-ROD, CARBON/PEEK, MULTI-CURVED, TL1, Ø 6.0 X 300 MM

MDR report key: 20985687 · Received December 20, 2024

Report

Report Number: 3006493760-2024-00006
Event Type: Injury
Date Received: December 20, 2024
Date of Event: December 10, 2024
Report Date: December 20, 2024
Manufacturer: ICOTEC AG
Product Code: NKB
PMA / PMN Number: K232628
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
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 UDI-PI. ANALYSIS OF THE RELEVANT PRODUCTION RECORDS OF THE RODS 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 THREE SIMILAR EVENTS WITH THIS DEVICES TO DATE. THE EXPLANTED IMPLANTS ARE NOT AVAILABLE FOR INVESTIGATION AS THEY WERE DISCARDED BY HOSPITAL STAFF. INVESTIGATION IS STILL ONGOING. 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 WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM AND A NON-ICOTEC CAGE IN A SURGERY ((B)(6) 2024)). 6 WEEKS POST-OP, IT WAS DETECTED THAT THE TWO PEDICLE RODS HAVE BROKEN AND THE CAGE HAS MOVED. A REVISION SURGERY WAS PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2169161	VADER PEDICLE SYSTEM, S-ROD, CARBON/PEEK, MULTI-CURVED, TL1, Ø 6.0 X 300 MM	VADER PEDICLE SYSTEM, S-ROD, CARBON/PEEK, MULTI-CURVED, TL1, Ø 6.0 X 300 MM	NKB	ICOTEC AG	16-60-2MC30-3	23/01

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention