FDA Adverse Event Injury Summary report: N

MID-C 125 LP

MDR report key: 14262959 · Received May 2, 2022

Report

Report Number: 3013461531-2022-00016
Event Type: Injury
Date Received: May 2, 2022
Report Date: April 30, 2022
Manufacturer: APIFIX LTD
Product Code: QGP
PMA / PMN Number: H170001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

FIRST INVESTIGATION: PRODUCTION PROCESS ANALYSIS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO SPECIFICATION. USER (SURGEON AND PATIENT) INFORMATION ANALYSIS: THE PATIENT WAS IMPLANTED WITH THE MID-C 125 LP ON (B)(6) 2021. POST-OP X-RAYS DEMONSTRATE THAT THE SYSTEM WAS AT END OF WAY AT 1 MONTH FOLLOW-UP AND THE CURVE WAS CORRECTED TO 26°. 6 MONTHS POST-OP THE SURGEON DECIDED TO PERFORM AN ELECTIVE REPLACEMENT OF THE DEVICE WITH A STANDARD MID-C 125 AND POSITIONED 1-LEVEL UP, THE CURVE WAS MEASURED 25°. RISK ASSESSMENT: REOPERATION EVENTS ARE A KNOWN RISK THAT WAS ASSESSED AND RECORDED BY THE PRODUCT RISK ASSESSMENT DMS-777 REV Q THIS COMPLAINT DOES NOT CHANGE THE OCCURRENCES RATE.

Description of Event or Problem · 0

PATIENT (B)(6) INITIAL SURGERY ON (B)(6) 2021 USING MID-C 125 LP TYPE WHICH IS NOT APPROVED IN US. THE PATIENT IS SCHEDULED FOR AN ELECTIVE REVISION SINCE THE IMPLANT REACHING ITS FULL ELONGATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2074388	MID-C 125 LP	POSTERIOR RATCHETING ROD SYSTEM,	QGP	APIFIX LTD	MID-C 125 LP	AF-12-065-20

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention