NA 04.130.355Recalls & reported problems
Synthes GmbH · 2.0MM TI VAL CONDYLAR PLATE 2 HOLES HEAD-6 HOLES SHAFT · Class 2 · Implant
Data updated Oct 16, 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 10886982113528), received between Feb 2, 2021 and Feb 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2021Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT FOUR (4) 1.5MM SCREWS BROKE DURING THE INSERTION INTO MULTIPLE VARIABLE ANGLE (VA) HAND PLATES. AFTER EACH ATTEMPT INTO NEW PLATES, THE PLATES WERE REPOSITIONED TO AVOID THE BROKEN SCREWS IN THE PATIENT. THE SURGEON WAS ADVISED TO ONLY FINGER TIGHTEN WHILE INSERTING, HOWEVER THE SCREWS KEPT BREAKING. THERE WAS A 45 MINUTE SURGICAL DELAY. THE SCREW HEADS SNAPPED OFF AND THE BROKEN SCREWS WERE LEFT IN THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: 1.5MM TI VAL Y-PLATE 3 HOLES HD-7 HOLES SHAFT (PRODUCT # 04.130.253, LOT # 70P8809, QUANTITY 1); 1.5MM TI VAL STRUT PLATE 8 HOLES-OBLIQUE-LEFT (PRODUCT # 04.130.259, LOT # UNKNOWN, QUANTITY 1); 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 11MM (PRODUCT # 04.214.111, LOT # UNKNOWN, QUANTITY 1); 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 12MM (PRODUCT # 04.214.112, LOT # UNKNOWN, QUANTITY 1); 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 15MM (PRODUCT # 04.214.115, LOT # UNKNOWN, QUANTITY 1); 2.0MM TI VAL STRAIGHT PLATE 6 HOLES (PRODUCT # 04.130.350, LOT # 70P9866, QUANTITY 1); 1.5MM TI CORTEX SCR SLF
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11266286 ↗
Other PLATE, FIXATION, BONE devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page