A.L.P.S. mvXRecalls & reported problems across all models
Tyber Medical, LLC · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
18 open recalls name at least one A.L.P.S. mvX model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 18
We found 25 models of A.L.P.S. mvX by Tyber Medical, LLC in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2024 and May 13, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 reports).
18 FDA recall records name at least one of these models by its device identifier, 18 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
A.L.P.S. mvX recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1226-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1225-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1224-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1223-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1222-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1221-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1220-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1219-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1218-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1217-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1216-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1215-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1214-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1213-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1212-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1211-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1210-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jan 21, 2025Open, Classified
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Z-1209-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported A.L.P.S. mvX problems
Device problems
- Fracture5
- Break1
- Difficult or Delayed Positioning1
- Osseointegration Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- Bone Fracture(s)1
- Insufficient Information1
- Nonunion/Delayed-union Bone Fracture1
A.L.P.S. mvX models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- A.L.P.S. mvX™ 770708042Plate, fixation, bone1 recall1 report
- A.L.P.S. mvX™ 770708041Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770708061Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770708062Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770708081Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770708082Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770708101Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770708102Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770708121Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770708122Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770715061Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770715062Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770715101Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770715102Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770715121Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770715122Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770715161Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770715162Plate, fixation, bone1 recall0 reports
- A.L.P.S. mvX™ 770150009Screw, fixation, bone1 report
- A.L.P.S. mvX™ 770150010Screw, fixation, bone1 report
- A.L.P.S. mvX™ 770300050Screw, fixation, bone1 report
- A.L.P.S. mvX™ 770002182BIT, DRILL1 report
- A.L.P.S. mvX™ 770240026Screw, fixation, bone1 report
- A.L.P.S. mvX™ 770714101Plate, fixation, bone1 report
- A.L.P.S. mvX™ 770714102Plate, fixation, bone1 report
Recent A.L.P.S. mvX adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, A SCREW BROKE INSIDE OF THE CANAL. IT WAS A METACARPAL NAIL OUT OF THE MVX HAND SYSTEM. WE HAD TO TRY TO REMOVE THE NAIL WHICH WAS UNSUCCESSFUL. THERE WAS MORE BONE REMOVAL BECAUSE OF THE BROKEN NAIL. ADD ANOTHER HOUR AND A HALF TO THE CASE. NAIL HAD TO STAY IN.
Patient problems: Foreign Body In Patient
MAUDE report 25160834 ↗MalfunctionJul 8, 2025Fracture; Fracture
1.5MM MVX HAND PLATE WAS SELECTED, 1ST 1.5MM CORTEX SCREW WAS INSERTED INTO THE PLATE. 2ND SCREW GOT CORTICAL FIXATION, WHEN ADVANCING THE 1.5MM X 9MM SCREW THE HEAD SHEARED OFF. OPENED A BURR TO CUT AROUND THE BONE TO RETRIEVE THE SHAFT OF THE SCREW. INCREASE IN ANESTHESIA TIME FOR PATIENT AND EXTRA COSTS ADDED DUE TO OPENING UP BURRS, ETC TO REMOVE THE RETAINED SCREW SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440808 ↗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 ↗MalfunctionJun 13, 2025Fracture; Fracture
SURGEON WAS USING 1.5MM SCREWS FROM THE MVX HANDSET AND THE SCREW HEAD POPPED OFF OF THE SCREW DURING HAND TIGHTENING. THE SCREWS HAD TO BE REMOVED AND THE SURGERY WAS PROLONGED ABOUT 30-45 MINUTES TO GET THE BROKEN SCREW OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22205947 ↗MalfunctionApr 4, 2025Fracture; Fracture
SALES REP STATED THAT THE INITIAL CASE WAS COMPLETED IN END JUNE/EARLY JULY. IT WAS A 23 YR OLD FEMALE APPROX 180 LBS. THE MECHANISM OF INJURY WAS A GUNSHOT WOUND TO THE ANKLE. SHE STATED THERE WAS ANKLE WAS A MESS AND THE SURGEON SAID HE EXPECTED HEALING MAY BE AN ISSUE. THE FACTURE WAS A NON-UNION WHICH IS WHY THE PLATE EVENTUALLY BROKE. THE SURGEON CUT OUT THE BAD BONE, FILLED IT WITH BONE CEMENT AND PLACED ANOTHER AL TIBIA PLATE IN THE REVISION SURGERY.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21777916 ↗MalfunctionDec 31, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning
SURGEON TRIED PUTTING IN SCREW INTO OBLONG HOLE TOWARDS TOP OF THE ANTEROLATERAL DISTAL TIBIA PLATE AND SCREW HEAD BROKE OFF FAIRLY EASILY. HE THEN PUT A SCREW IN JUST PROXIMAL TO THE FIRST AND SCREW HEAD PASSED THROUGH THE PLATE AND WAS STUCK UNDER PLATE. 2-HOUR SURGICAL DELAY NOTED AFTER SURGEON TRIED TO REMOVE BROKEN SCREW AND THE SCREW UNDER THE PLATE. SCREW WAS DISCARDED AND PLATE WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21049118 ↗InjuryDec 31, 2024Osseointegration Problem; Osseointegration Problem
THE BONE FRAGMENT BROKE ON THE INTERFRAG SCREW AND THE SURGEON FELT THAT ONE POINT OF FIXATION PROXIMALLY WAS NOT ADEQUATE FOR THIS TO HEAL SO WE OPTED TO REVISE THE PLATE AND PUT ON A DIFFERENT PLATE.
Patient problems: Bone Fracture(s)
MAUDE report 21049117 ↗MalfunctionOct 11, 2024Fracture; Fracture
FROM COMPLAINANT: FROM STAFF: PATIENT WITH PRIOR ANKLE FRACTURE AND SUBSEQUENT SURGERY TO REMOVE HARDWARE WITH RETAINED BROKEN IMPLANTS LEFT IN PLACE WHO PRESENTED WITH A NEW FRACTURE OF THE SAME ANKLE. DURING SURGERY ( (B)(6) 2024) THE DRILL BIT BROKE AFTER COMING IN CONTACT WITH OTHER HARDWARE. IT WAS BURIED IN THE BONE, AND SURGEON MADE THE DECISION THAT THE RISK OF REMOVING IT OUTWEIGHED THE RISK OF LEAVING IT IN PLACE. RETAINED BROKEN HARDWARE FROM THE PRIOR SURGERIES WAS ALSO LEFT IN PLACE AND THIS HAD BEEN DISCUSSED WITH THE PATIENT BEFORE SURGERY. BOTH THE PATIENT AND HER FAMILY HAVE BEEN NOTIFIED AND AGREE WITH THIS DECISION. FROM OPERATIVE REPORT: OF NOTE THE DURAL-BASED DID BREAK WHILE PLACEMENT OF THE SCREWS DUE TO HARDWARE IN THE DISTAL TIBIA.
Patient problems: Foreign Body In Patient
MAUDE report 20432554 ↗
Other Tyber Medical, LLC products
All Tyber Medical, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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