DCS 281.980Recalls & reported problems
Synthes GmbH · 95 DEG DCS® PLATE 8 HOLES/146MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982178121), received between May 4, 2018 and Jan 12, 2022 — classified as 3 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
- Break1
Patient problems
- Bone Fracture(s)2
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, A FRACTURE OCCURRED ABOVE A SYNTHES DCS CONSTRUCT. THE HARDWARE WAS SUCCESSFULLY REMOVED AND A FEMORAL RECON NAIL WAS PLACED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) UNK - NAIL HEAD ELEM: DHS/DCS. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 13238058 ↗InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, A FRACTURE OCCURRED ABOVE A SYNTHES DCS CONSTRUCT. THE HARDWARE WAS SUCCESSFULLY REMOVED AND A FEMORAL RECON NAIL WAS PLACED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 95 DEG DCS PLATE 8 HOLES/146MM. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 13238057 ↗InjuryMay 4, 2018Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH THE 95 DEGREE DYNAMIC CONDYLAR SCREW (DCS) PLATE ON (B)(6) 2018. POSTOPERATIVELY THE PLATE BROKE IN THE PATIENT. POSTOPERATIVELY ON AN UNKNOWN DATE THE PATIENT UNDERWENT IMMEDIATE SURGICAL TREATMENT OF CONSOLIDATION DELAY AND PROXIMAL FEMUR REFRACTION (DCS FAILURE) WITHOUT INTERCURRENCES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 7486756 ↗
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- 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.
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