Equinoxe 320-35-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862534927), received between Mar 19, 2023 and Jan 3, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE EQUINOXE SHOULDER STUDY THAT THIS 77 Y/O FEMALE PATIENT EXPERIENCED AN INTRA-OP CORACOID FRACTURE WITH REDUCTION AND HAD A REMOVAL OF A GPS TRACKER. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 18435366 ↗
• InjuryMay 24, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 70 YO FEMALE PATIENT EXPERIENCED A SCAPULAR SPINE FRACTURE (TYPE 2). THE PATIENT WAS UNAWARE THAT SHE HAD THE ACROMIAL STRESS FRACTURE. THERE WAS NO TRAUMA. THE PATIENT WAS ASYMPTOMATIC. THE OUTCOME WAS LAST KNOWN AS CONTINUING.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 16999256 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED, A FEMALE PATIENT WHO HAD A RIGHT TOTAL SHOULDER ARTHROPLASTY ON (B)(6)2023, AT A 6 WEEK POST OP FOLLOW UP APPOINTMENT, A CORACOID TIP AVULSION FRACTURE WAS DETERMINED. THE SURGEON INDICATED HE ASSUMED IT WAS RELATED TO USING CORACOID TRACKER/SCREWS. THE PATIENT WAS TREATED NON-OPERATIVE. NO FURTHER INFORMATION.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 16807226 ↗
• InjuryMar 19, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY, THAT INTRA-OP, THE 77 YO FEMALE PATIENT SUSTAINED A SCAPULAR FRACTURE OF THE CORACOID THROUGH SCREW HOLES FROM TRACKER ARM. THE ACTION TAKEN WAS REPAIR WITH SUTURE FIXATION. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2022.

  Patient problems: Bone Fracture(s)

  MAUDE report 16570579 ↗