SONICWELD RX, STERILE 52-521-35-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888118001143), received between Mar 2, 2017 and Mar 2, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2017Device Operates Differently Than Expected

  THREE SONICPIN IMPLANTS WERE IMPLANTED TO FIXATE RIB GRAFTS TO THE LEFT AND RIGHT CONDYLAR HEAD. THIS WAS COMPLETED SUCCESSFULLY AND PATIENT WAS PUT IN RUBBER BANDS INSTEAD OF WIRING JAW SHUT WHICH ALLOWED SOME MOVEMENT POST OPERATIVELY. DURING POST-OP CONSULTS THAT EVENING AND NEXT DAY THE PATIENT WAS PROGRESSING WELL. UPON ROUNDS ON 2ND DAY POST-OP PATIENTS OCCLUSION HAD OPENED AND AFTER REVIEW OF THE CT SCAN IT WAS APPARENT THE FIXATION HAD FAILED. PATIENT UNDERWENT ANOTHER OPERATION THIS TIME IMPLANTING BICOTRICAL AND MONOCORTICAL RESORB-X PINS AND RESORB-XG PLATES. THE PATIENT HAS A TITANIUM ALLERGY.

  Patient problems: Wound Dehiscence

  MAUDE report 6373188 ↗