REFLEX HYBRID 48510614Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327270853), received between Jun 14, 2018 and Jun 14, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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.

• InjuryJun 14, 2018Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT HE PATIENT STARTED HAVING ONGOING ISSUES SINCE SURGERY WHICH INCLUDE ITCHING, FATIGUE, MYALGIA, FURTHER INTO THE YEAR HAVING GASTRO-INTESTINAL ISSUES, NECK PAIN, NUMBNESS IN ARMS AND HANDS AS WELL AS FACE, UNCOMFORTABLE SWALLOWING, SKIN BUMPS AND BREAK OUTS AROUND NECK, CHEST AND UPPER BACK, AND BRAIN FOG. PATIENT HAS HAD TESTING DONE, HAS TESTED POSITIVE AUTOIMMUNE ISSUE, 10 LB. WEIGHT LOSS IN A SHORT PERIOD WITHOUT REASON. DOC SEVERED LONG THORACIC NERVE AND DAMAGED C7 NERVE.

  Patient problems: Injury; Itching Sensation; Nerve Damage; Numbness; Swelling; Weight Changes

  MAUDE report 7603493 ↗