FDA Adverse Event Malfunction Summary report: N

A.L.P.S. MVX¿

MDR report key: 22148770 · Received June 5, 2025

Report

Report Number
22148770
Event Type
Malfunction
Date Received
June 5, 2025
Date of Event
May 5, 2025
Report Date
May 23, 2025
Manufacturer
TYBER MEDICAL LLC
Product Code
HWC
Product Problem
Yes
Report Source
User Facility report
Reporter Location
ME
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

FROM STAFF: SURGEON BROKE A SCREW DURING SURGERY. THE PLAN WAS TO REMOVE THE SCREW TO REMOVE THE PLATE AND THEN REPLACE THE SCREW. THE SCREW HEAD BROKE IN THE PROCESS. THIS ALLOWED SURGEON TO REMOVE THE PLATE AND KEEP THE SHAFT OF THE SCREW IN PLACE AS SURGEON HAD INTENDED. SURGEON BELIEVED THAT REMOVING THE SCREW WOULD HAVE CREATED MORE HARM THAN LEAVING IT IN PLACE. SURGEON NOTIFIED THE PATIENT AND THE FAMILY AND DICTATED THIS IN HIS PROGRESS NOTE. FROM OPERATIVE REPORT: I WAS PLANNING ON REPLACING THE TWO SCREWS THAT CAPTURED THE BUTTERFLY FRAGMENT. I REMOVED THE PLATE. OF THE TWO INTERFRAGMENTARY SCREWS, ONE OF THE SCREW HEADS BROKE OFF. IT WAS STILL PROVING GOOD CAPTURE OF THE INTERFRAGMENTARY SEGMENT, AND I ELECTED TO LEAVE IT IN PLACE BECAUSE I THINK THE HARM OF REMOVING IT OUTWEIGHED THE HARM OF LEAVING IT IN. THE SECOND INTERFRAGMENTARY SCREWS WAS REMOVED WHILE REMOVING THE PLATE AND THEN PLACED BACK IN THE SAME POSITION TO HOLD THE POSTERIOR BUTTERFLY FRAGMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
77351 A.L.P.S. MVX¿ SCREW, FIXATION, BONE HWC TYBER MEDICAL LLC 770240026

Patients

Seq Age Sex Outcome Treatment
1 24 YR Male