FDA Adverse Event Injury Summary report: N

CONCORDE PROTI 5 DG, 9X8X23 MM

MDR report key: 14688968 · Received June 14, 2022

Report

Report Number: 3012966183-2022-00023
Event Type: Injury
Date Received: June 14, 2022
Date of Event: May 16, 2022
Report Date: June 14, 2022
Manufacturer: TYBER MEDICAL
Product Code: MAX
UDI-DI: 10705034352015
PMA / PMN Number: K172185
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

A HISTORICAL DATA REVIEW WAS CONDUCTED ON THE PART NUMBER. A TOTAL OF 5 COMPLAINTS FOR UNRELATED ISSUES WERE IDENTIFIED. THERE WERE NO CAPAS OR NON-CONFORMANCES RELATED TO THIS PART AT THE TIME OF THIS REVIEW. AS IT WAS REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED AND THE INCISION CLOSED PRIOR TO THE ADVERSE EVENT OCCURRENCE. ADDITIONALLY, THE REPORT ALSO STATES "THERE WAS NO DEFECTIVENESS INVOLVED WITH THE DEVICES". NO FURTHER INFORMATION WAS PROVIDED BY THE COMPLAINANT TO ASSIST WITH THIS INVESTIGATION. ALTHOUGH THE COMPLAINANT CLEARLY STATES THAT THE EVENT WAS NOT DUE TO FORM, FIT OR, FUNCTION OF THE IMPLANTED DEVICE A ROOT CAUSE IS INDETERMINATE.

Description of Event or Problem · 0

IT WAS REPORTED THAT THIS WAS A PLIF FOR TREATING SPONDYLOLISTHESIS (IN ONE INTERVERTEBRAL LESION) ON (B)(6) 2022. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. HOWEVER, THE PATIENT'S HEART SUDDENLY STOPPED DURING CLOSING INCISION. THEY CAME TO THE FOLLOWING CONCLUSIONS. THERE WAS NO DEFECTIVENESS INVOLVED WITH THE DEVICES. THE HEART STOPPAGE DID NOT BECOME FATAL. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1627581	CONCORDE PROTI 5 DG, 9X8X23 MM	INTERBODY SPACERS	MAX	TYBER MEDICAL	188823408		10705034352015

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other