Straight Plate, 4.5mm 21103-10Recalls & reported problems
I.T.S. GmbH · Straight Plate, 4.5mm, 10-Hole · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09120034304750), received between Mar 2, 2018 and Jul 3, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K060156); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Break1
- Insufficient Device Problem Information1
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A STRAIGHT PLATE 4.5MM 10-HOLE BROKE 1 MONTH POST-OPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2019. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE.
Patient problems: No Information
MAUDE report 8756586 ↗InjuryMar 2, 2018Break; Break
IT WAS REPORTED THAT A STRAIGHT PLATE 4.5MM BROKE 4 MONTHS POST-OP AND AN ORIF WITH HARDWARE REMOVAL WAS PERFORMED AT AN UNKNOWN DATE.
Patient problems: No Information
MAUDE report 7308996 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060156. One submission often covers many models, so check the product and lot details in each record.
- Z-1599-2026 · Jan 23, 2026 · Open, ClassifiedI.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404
- Z-1598-2026 · Jan 23, 2026 · Open, ClassifiedI.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Fore
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- PRECICE® Plating System LP4.5-PLF4BNuvasive 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-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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