ProForma® 050906Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40653405051412), received between Apr 26, 2022 and Apr 26, 2022 — 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.

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.

• InjuryApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 050906, PROFORMA HG 4.5 CANN STRAIGHT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND ¿WHEN THE PROFORMA WAS INSERTED INTO THE PATIENT'S BODY, THE METAL MARKER AT THE TIP DID NOT CONTRAST. WHEN THE PROFORMA WAS REMOVED, THE METAL MARKER AT THE TIP WAS NOT ATTACHED. HOWEVER, THE SURGEON DID NOT REMEMBER IF THE METAL MARKER WAS ATTACHED FROM THE BEGINNING.¿ THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ANY PROLONGED HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND THERE WAS NO DELAY. FURTHER ASSESSMENT FOUND THAT IT IS NOT KNOWN IF THE DEVICE WAS INSPECTED BEFORE USE. IT IS NOT KNOWN IF A FRAGMENT FELL INTO THE PATIENT OR IF THE METAL MARKER WAS ATTACHED FROM THE BEGINNING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THIS REPORT IS BEING RAISED ON THE BASIS OF POTENTIAL INJURY BASED UPON THE LACK OF INFORMATION REGARDING IF METAL MARKER REMAINS IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14205915 ↗