NA 214.860Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982154798), received between Jun 7, 2018 and Jun 7, 2018 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS PUMPING GAS AND STEPPED OVER GAS PUMP HOSE WHEN HE TRIPPED AND FELL ONTO HIS LEFT SIDE AND INJURED HIS LEFT HIP ON (B)(6) 2014. PATIENT REPORTED THAT HE STRAIGHTENED HIS LEFT LEG AND HEARD A POP AND SOME PAIN. THE PATIENT REPORTED HAVING SOME RECURRENT SCIATICA SYMPTOMS WITH HIS RIGHT HIP AND KNEE AND HIS KNEE WOULD PERIODICALLY GIVE OUT. PATIENT BELIEVES HIS RIGHT LEG MAY HAVE BUCKLED, CAUSING THE FALL/FRACTURE OF HIS LEFT LOWER EXTREMITY. PATIENT HAD SEVERE PAIN AND WAS UNABLE TO AMBULATE THEREAFTER. HIS RIGHT LEG HAD SOME CONTUSIONS FOLLOWING THE FALL. IT WAS NOTED THAT HIS LEFT LOWER EXTREMITY WAS IN EXTERNAL ROTATION. PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION FOR A LEFT SUBTROCHANTERIC FEMUR FRACTURE ON (B)(6) 2014. THERE WAS OOZING FROM FRACTURE SITE WHICH REQUIRED INTRAOPERATIVE TRANSFUSION WITH 5 UNITS OF PACKED RED BLOOD CELLS. THE 9-HOUR SURGERY WAS COMPLICATED AND PROLONGED INCLUDING ONE HOUR OF TRANSFUSION. ESTIMATED BLOOD LOSS DURING SURGERY WAS APPROXIMATELY 2 LITERS. PRELIMINARY X-RAYS TAKEN ON (B)(6) 2014 OF THE LEFT HIP SHOWED SEVERE POSTERIOR SAG OF THE PROXIMAL SEGMENT AND ANTERIOR THIGH. TO HELP REDUCE THE POSTERIOR SA

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7579351 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS PUMPING GAS AND STEPPED OVER GAS PUMP HOSE WHEN HE TRIPPED AND FELL ONTO HIS LEFT SIDE AND INJURED HIS LEFT HIP ON (B)(6) 2014. PATIENT REPORTED THAT HE STRAIGHTENED HIS LEFT LEG AND HEARD A POP AND SOME PAIN. THE PATIENT REPORTED HAVING SOME RECURRENT SCIATICA SYMPTOMS WITH HIS RIGHT HIP AND KNEE AND HIS KNEE WOULD PERIODICALLY GIVE OUT. PATIENT BELIEVES HIS RIGHT LEG MAY HAVE BUCKLED, CAUSING THE FALL/FRACTURE OF HIS LEFT LOWER EXTREMITY. PATIENT HAD SEVERE PAIN AND WAS UNABLE TO AMBULATE THEREAFTER. HIS RIGHT LEG HAD SOME CONTUSIONS FOLLOWING THE FALL. IT WAS NOTED THAT HIS LEFT LOWER EXTREMITY WAS IN EXTERNAL ROTATION. PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION FOR A LEFT SUBTROCHANTERIC FEMUR FRACTURE ON (B)(6) 2014. THERE WAS OOZING FROM FRACTURE SITE WHICH REQUIRED INTRAOPERATIVE TRANSFUSION WITH 5 UNITS OF PACKED RED BLOOD CELLS. THE 9-HOUR SURGERY WAS COMPLICATED AND PROLONGED INCLUDING ONE HOUR OF TRANSFUSION. ESTIMATED BLOOD LOSS DURING SURGERY WAS APPROXIMATELY 2 LITERS. PRELIMINARY X-RAYS TAKEN ON (B)(6) 2014 OF THE LEFT HIP SHOWED SEVERE POSTERIOR SAG OF THE PROXIMAL SEGMENT AND ANTERIOR THIGH. TO HELP REDUCE THE POSTERIOR SA

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7579349 ↗