Grappler R3FLEX Stabilization System P82-001-1237-SKRecalls & reported problems
Paragon 28, Inc. · Grappler R3FLEX Single Implant Kit · Class 2
Data updated Oct 16, 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 00889795128140), received between Feb 6, 2026 and Feb 6, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
- Positioning Failure1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2026Positioning Failure; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT PLACEMENT UTILIZING TIBIAL AND FIBULAR TUNNELS, THE IMPLANT COULD NOT BE ADVANCED AND INTRA-OPERATIVE DIFFICULTIES OCCURRED WITH THE INSERTER AND SUTURE. FOLLOWING DRILLING AS PER THE SURGICAL TECHNIQUE, THE IMPLANT WAS ADVANCED THROUGH THE FIBULAR TUNNEL AND THE TIBIAL TUNNEL WAS SOUGHT. AFTER INITIAL RESISTANCE, A MALLET WAS USED PER TECHNIQUE; FLUOROSCOPIC IMAGING SHOWED THE IMPLANT HAD NOT ADVANCED. THE SURGEON ATTEMPTED TO REMOVE THE IMPLANT THROUGH THE FIBULAR TUNNEL TO REDRILL AND VERIFY TRAJECTORY BUT WAS UNABLE TO RETRIEVE IT. A SUBSEQUENT ATTEMPT TO LOCATE THE TIBIAL TUNNEL WAS MADE, AND AFTER APPLYING SIGNIFICANT FORCE THE IMPLANT ADVANCED SLIGHTLY, THEN THE INSERTER TIP DETACHED FROM THE GRAY HANDLE. WHEN THE SURGEON LIGHTLY TUGGED THE GRAY HANDLE TO DEPLOY THE SOCK, THE SUTURE BROKE AND EXITED THROUGH THE FIBULAR TUNNEL WHICH RESULTED IN THE SOCK BEING RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 24276778 ↗
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- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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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