FDA Adverse Event Injury Summary report: N

VADER® PEDICLE SYSTEM

MDR report key: 25345302 · Received May 31, 2026

Report

Report Number: 3012602431-2026-00053
Event Type: Injury
Date Received: May 31, 2026
Date of Event: March 11, 2026
Report Date: May 31, 2026
Manufacturer: ICOTEC AG
Product Code: NKB
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ICOTEC ATTEMPTED TO OBTAIN THE RETRIEVED DEVICES FOR INVESTIGATION. TO DATE, THESE HAVE NOT BEEN MADE AVAILABLE. ANALYSIS OF THE RELEVANT PRODUCTION RECORDS OF THE PEDICLE SCREWS DID NOT IDENTIFY ANY ANAMOLIES THAT COULD BE A CAUSE OF THE EVENT. 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. DATA RELATING TO MANUFACTURING DATE IS NOT ON THE LABEL AS UDI-PI.

Description of Event or Problem · 0

MFR REPORT #: 3006493760-2026-00004. A PATIENT IMPLANTED WITH AN ICOTEC PEDICLE SYSTEM ((B)(6) 2023) REQUIRED A REVISION SURGERY ((B)(6) 2026; LOOSENED NUT SCREWS, TWO BROKEN PEDICLE SCREWS; MDR NO. 3006493760-2026-00003). THE SURGEON DECIDED TO REPLACE THE ENTIRE SYSTEM. WHEN ATTEMPTING TO REMOVE THE OSSEOINTEGRATED PEDICLE SCREWS, SIX OF THEM BROKE. THE SURGEON DECIDED TO LEAVE THE FRACTURED SHAFTS IN PLACE AND TO EXTEND THE CONSTRUCT TO ADDITIONAL LEVELS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
217843	VADER® PEDICLE SYSTEM	VADER® PEDICLE SYSTEM, SCREW, CARBON/PEEK, POLYAX., FEN	NKB	ICOTEC AG	NOT REPORTED

Patients

Seq	Age	Sex	Outcome	Treatment
1