Clavicle Plate 21121-8Recalls & reported problems
I.T.S. GmbH · Clavicle Plate, 8-Hole · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09120034304415), received between Jan 8, 2019 and Jul 12, 2019 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K050852); 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
- Insufficient Device Problem Information3
Patient problems
- No Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A CLAVICLE PLATE 2.5MM, 8-HOLE BROKE POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2019.
Patient problems: No Information
MAUDE report 8783902 ↗MalfunctionJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A CLAVICLE PLATE, MEDIAL, 2.5MM, 8-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE UNKNOWN. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE.
Patient problems: No Information
MAUDE report 8225821 ↗MalfunctionJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A CLAVICLE PLATE, MEDIAL, 2.5MM, 8-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE UNKNOWN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013.
Patient problems: No Information
MAUDE report 8225471 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K050852. One submission often covers many models, so check the product and lot details in each record.
- Z-1593-2026 · Jan 23, 2026 · Open, ClassifiedClaviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-1
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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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