A.L.P.S. mvX™ 770240026Recalls & reported problems
Tyber Medical, LLC · 2.4MM NON-LOCKING SCREW 26MM · Class 2 · Implant
All models of A.L.P.S. mvX (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00196449013128), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Fracture; Fracture
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. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : 1. REMOVAL OF EXTERNAL FIXATOR UNDER ANESTHESIA. 2. INTRAMEDULLARY NAIL FIXATION LEFT TIBIA. 3. INTRAMEDULLARY NAIL FIXATION LEFT TIBIAL SHAFT FRACTURE. 4. OPEN REDUCTION
Patient problems: Insufficient Information
MAUDE report 22350833 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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