FDA Adverse Event Injury Summary report: N

ICOTEC PEDICLE SYSTEM, SCREW, CARBON/PEEK

MDR report key: 18238925 · Received November 30, 2023

Report

Report Number: 3006493760-2023-00004
Event Type: Injury
Date Received: November 30, 2023
Date of Event: October 18, 2023
Report Date: November 30, 2023
Manufacturer: ICOTEC AG
Product Code: NKB
PMA / PMN Number: K200596
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ANALYSIS OF THE RELEVANT PRODUCTION RECORDS DID NOT IDENTIFY ANY ANOMALIES THAT COULD BE A CAUSE OF THE EVENTS. DURING THE INVESTIGATION IT WAS REVEALED THAT NOT THE ICOTEC SPECIFIC TAPS WERE USED FOR TAPPING. TAPS OF A THIRD PARTY MANUFACTURER WERE USED. ACCORDING TO THE IFU ONLY ICOTEC SPECIFIC INSTRUMENTS ARE INTENDED FOR USE WITH THE ICOTEC IMPLANTS. ICOTEC HAS REQUESTED THE HOSPITAL TO RETURN THE AFFECTED IMPLANTS, BUT THE HOSPITAL WILL NOT RELEASE THEM. NEITHER THE DEVICE NOR APPLICABLE IMAGES WERE PROVIDED TO ICOTEC FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATIONS AND THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE DEFINITE ROOT CAUSE FOR THE INCIDENT.

Description of Event or Problem · 0

A PATIENT WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM IN A SURGERY (8. DEZ 2022). DURING A POST-OP CHECK, IT WAS DETECTED THAT ONE OF THE VERTEBRAL BODIES COLLAPSED AND THREE PEDICLE SCREWS OUT OF NINE HAVE BROKEN AT THE SCREW HEAD. A REVISION SURGERY HAD TO BE CARRIED OUT (18. NOV 2023). DURING THE REVISION SURGERY, IT WAS REALIZED THAT ONE ADDITIONAL SCREW HAD BECOME LOOSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1884148	ICOTEC PEDICLE SYSTEM, SCREW, CARBON/PEEK	PEDICLE SCREW SYSTEM	NKB	ICOTEC AG	16-6022-55540, 16-6022-55545	UNCLEAR

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention