NA 02.100.120Recalls & reported problems
Synthes GmbH · 3.5MM LOCKING LOW PROFILE RECON PLATE 20 HOLES · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982028532), received between Jun 22, 2020 and Jun 22, 2020 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT CLAVICLE HARDWARE REMOVAL OF PREVIOUS PLATE FRAGMENTS AND SUTURES, LEFT STERNOCLAVICULAR JOINT OPEN BONE GRAFTING, AND REMOVAL OF STERNAL PLATES. THE PLATE HAD PULLED OUT OF THE STERNUM, STERNAL LOCKING SCREWS THROUGH THE STERNUM WERE LOOSE AND THE CONSTRUCT OVERALL WAS LOOSE ALL THE WAY UP INTO THE FIRST SCREW HOLE IN THE PLATE AND A PORTION OF THE PLATE WAS LEFT IN PLACE AS IT WAS HOLDING SOME PORTION OF THE RECONSTRUCTION SITE INTACT. THERE WERE SOME FIBERS-END- BONE HEALING PRESENT AT THE LEFT STERNOCLAVICULAR RECONSTRUCTION SITE. ON (B)(6) 2017, THE PATIENT FELL CAUSING A STERNOCLAVICULAR JOINT AND HAS HAD A SIGNIFICANT PROBLEM AND MALALIGNMENT WITH HEALING CAUSING A SIGNIFICANT AMOUNT OF PAIN. ON (B)(6) 2017, THE PATIENT UNDERWENT BRONCHOSCOPY, LEFT MINI-THORACOTOMY WITH INSPECTION OF RIBS, PLACEMENT OF CHEST TUBES, LEFT MEDIAL CLAVICLE EXCISION, AND LEFT STERNAL CLAVICULAR JOINT RECONSTRUCTION WITH ALLOGRAFT X2 WITH SUPPLEMENTAL INTERNAL BRACE TO TREAT MULTIPLE RIB FRACTURES AND STERNOCLAVICULAR DISLOCATION USING NON-SYNTHES IMPLANTS. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT ARTHRODESIS OF THE STERNOCLAVI
Patient problems: No Code Available
MAUDE report 10181646 ↗
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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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