SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Left B-111200Recalls & reported problems
Bonebridge AG · 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 07640187462630), received between Jan 13, 2026 and Jan 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2026Detachment of Device or Device Component
ON 16 DECEMBER, BONEBRIDGE RECEIVED MARKET FEEDBACK FROM (B)(6) SWITZERLAND REPORTING AN OSTEOSYNTHESIS MATERIAL REMOVAL (OSME) AND REVISION OSTEOSYNTHESIS PERFORMED AFTER THE 6-WEEK FOLLOW-UP DUE TO SECONDARY DISLOCATION OF THE DISTAL LOCKING SCREWS OF A SALGINA DISTAL RADIUS PLATE. THE TREATING SURGEON DESCRIBED THE PATIENT AS BEING VERY ACTIVE AND STATED THAT POSTOPERATIVE NON-COMPLIANCE WAS A HIGHLY LIKELY CONTRIBUTING FACTOR. ACCORDING TO THE SURGEON EARLY EXCESSIVE LOADING OF THE OPERATED HAND, INCLUDING SUPPORTING BODY WEIGHT SHORTLY AFTER SURGERY, WAS CONSIDERED A LIKELY CONTRIBUTING FACTOR. ACCORDING TO THE OPERATIVE REPORT, ALL DISTAL LOCKING SCREWS WERE INSERTED USING A TORQUE-LIMITING DEVICE WITH POWER ASSISTANCE AND WERE MANUALLY CHECKED AND RETIGHTENED AT THE END OF THE PROCEDURE. IMAGING & CLINICAL FINDINGS: POSTOPERATIVE IMAGING CONFIRMED THAT ALL DISTAL SCREWS WERE POSITIONED EXTRA-ARTICULARLY. AT THE 6-WEEK FOLLOW-UP, CT IMAGING SHOWED SECONDARY DISPLACEMENT OF THE DISTAL FRAGMENT BLOCK, WITH THE SCREWS REMAINING FIXED IN BONE WHILE THE FRAGMENT BLOCK HAD SUBSIDED RELATIVE TO THE PLATE. THIS FINDING INDICATES A LOSS OF LOCKING INTEGRITY AT THE SCREW-PLATE INTERFAC
Patient problems: Bone Fracture(s)
MAUDE report 24052100 ↗
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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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