Aequalis™ Ascend™ Flex DWF605ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386944598), received between Apr 26, 2019 and Oct 7, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

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

• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 PRIMARY SURGERY TOOK PLACE OF AEQUALIS ASCEND FLEX + AEQUALIS REVERSED II GLENOID. ON (B)(6) 2018 (ONSET DATE UNK (B)(6) 2017) ADVERSE EVENT WAS REPORTED, PSEUDOPARALYTIC RIGHT ARM DUE TO CERVICAL SPINE DEGENERATION AND SUBSEQUENT RADICULOPATHY. SUBJECT HAS BEEN HAVING INCREASING NECK ISSUES AND HAS BEEN ADVISED TO UNDERGO SURGICAL INTERVENTION. SUBJECT IS SEEKING A SECOND OPINION AND EMG TO UNDERSTAND THE PROBLEMS. SUBSEQUENTLY ON (B)(6) 2021, PATIENT SUSTAIN A C1 FRACTURE IN (B)(6) 2020 LEAVING HER UNABLE TO MOVE HER RIGHT ARM AT ALL NOW. PATIENT BEING FOLLOWED BY A NEUROSURGEON FOR CERVICAL SPINE ISSUES.

  Patient problems: Arthritis; Loss of Range of Motion; Muscle Weakness/Atrophy; Paralysis

  MAUDE report 12593798 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ROTATOR CUFF DEFICIENCY, POTENTIAL LOOSENING AND POTENTIAL INFECTION. SUBJECT NUMBER: (B)(6) (FROM PYROCARBON IDE STUDY).

  Patient problems: Joint Laxity; Muscle Weakness/Atrophy; Unspecified Infection

  MAUDE report 11497226 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY 5 MONTHS AFTER INITIAL SURGERY, DUE TO INFECTION. THE PATIENT ALSO HAD A HUMERAL FATIGUE FRACTURE DURING THE REVISION SURGERY. PATIENT ID: (B)(6).

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 10028424 ↗
• InjuryApr 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY 1 YEAR AFTER PRIMARY SURGERY, DUE TO ANTEROSUPERIOR ESCAPE. SUBJECT ID: (B)(6)".

  Patient problems: Joint Dislocation; Patient Problem/Medical Problem

  MAUDE report 8554657 ↗