Clavicle Plate 3.5mm 21122-8Recalls & reported problems
I.T.S. GmbH · Clavicle Plate 3.5mm, 8-Hole · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09120034305207), received between Jul 10, 2017 and Jan 9, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
- No Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT FIVE LOCKING SCREWS GOT LOOSE 3 WEEKS POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18474044 ↗MalfunctionJul 28, 2022Fracture; Fracture
IT WAS REPORTED THAT A 8-HOLE MEDIAL CLAVICLE PLATE BROKE APPROX. 4 MONTHS POST-OP. DIAGNOSIS NOT KNOWN.
Patient problems: Insufficient Information
MAUDE report 15121466 ↗MalfunctionJan 13, 2022Fracture; Fracture
A CLAVICLE PLATE MEDIAL 3.5MM, 8-HOLE BROKE AFTER AN UNKNOWN TIME PERIOD. NO FURTHER INFORMATION WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 13248503 ↗MalfunctionJan 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A CLAVICLE PLATE, MEDIAL, 3.5MM, 8-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2009. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2012.
Patient problems: No Information
MAUDE report 8225504 ↗InjuryJul 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
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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