DynaFORCE™ 7118-1818KTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815432023363), received between Dec 4, 2019 and Dec 27, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT THOUGHT THAT SHE MIGHT BE HAVING AN ALLERGIC REACTION TO A PLATE AFTER HER SURGERY. SHE HAD A CROSSROADS EXTREMITY SYSTEMS PLATE IMPLANTED APPROXIMATELY 14 WEEKS PRIOR TO (B)(6) 2022. THE IMPLANTS WILL NOT BE RECOVERED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DYNAFORCE IS A NITINOL SUPERELASTIC BONE STAPLE FOR USE IN SURGERY OF THE HAND AND FOOT FOR BONE FRAGMENT OSTEOTOMY FIXATION AND JOINT ARTHRODESIS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16053018 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  DOCTOR REPORTS THAT ON (B)(6) 2018 HE PERFORMED A 1ST, 2ND, AND 3RD TMT FUSION ON A PATIENT. DOCTOR USED A Z-ALPHA PLATE AND SCREWS WITH A 15MM HIMAX STAPLE FOR THE 1ST TMT FUSION PART OF THE PROCEDURE. FOR THE 2ND AND 3RD TMT FUSION HE USED HIMAX 18MM X 18MM X 18MM STAPLES. HE ALSO USED 2 COMPETITIVE SCREWS TO STABILIZE 1ST RAY OF THE FOOT TO THE 2ND RAY. AT SOME POINT POST-SURGERY, THE HIMAX STAPLES BROKE THAT WERE USED ON THE 2ND TMT AND 3RD TMT FUSIONS. DOCTOR REPORTS THAT THE PATIENT WAS NON-COMPLIANT AND WAS WALKING ON HER FOOT WITHIN THE 1 MONTH AFTER THE OPERATION. HE SAYS THAT THE CT SCAN SHOWS THAT THE 2ND AND 3RD TMT JOINTS STILL EXPERIENCED FUSION EVEN THOUGH THE PATIENT WAS NON-COMPLIANT AND THE STAPLES BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502243 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  DOCTOR PERFORMED AN MTP FUSION SURGERY ON (B)(6) 2019 THAT WAS A REVISION TO ANOTHER DOCTOR'S BUNION SURGERY DONE ON THE SAME PATIENT. AT SOME POINT POST-SURGERY ONE OF THE LEGS OF THE CLIP BROKE. NO REVISION AS PATIENT IS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501811 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  DOCTOR REPORTS THAT ON (B)(6) 2018 HE PERFORMED MULTIPLE MIDFOOT AND HINDFOOT FUSIONS ON A PATIENT WITH DIABETES AND DIABETIC NEUROPATHY. AT SOME POINT POST-OPERATION, TWO OF THE STAPLES BROKE ON THE LEGS OF THE IMPLANT. DOCTOR SAYS THE NAVICULAR EXPERIENCES AVASCULAR NECROSIS AND COLLAPSED POST-SURGERY. HE ALSO REPORTS THAT THIS PATIENT WAS NON-COMPLIANT AND WAS WALKING ON THEIR FOOT IN THE 1ST MONTH AFTER THE OPERATION. MOST OF THE AREAS FUSED EXCEPT FOR 1 SMALL PORTION, HE SAYS. ACCORDING TO THE FOLLOW-UP, DOCTOR SAYS THIS PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501806 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  DOCTOR REPORTS THAT ON (B)(6) 2018 HE PERFORMED A N-C FUSION OF THE MEDIAL, INTERMEDIATE, AND LATERAL CUNEIFORMS TO THE NAVICULAR BONE USING 2 HIMAX 18MMX18MMX18MM STAPLES AND 2 HIMAX 15MMX15MMX15MM STAPLES. HE SAYS THAT ONE OF THE 18MM HIMAX STAPLES BROKE ON THE PROXIMAL LEG AT SOME POINT POST-OPERATION. DOCTOR REPORTS THAT FUSION DID OCCUR IN THE JOINT BETWEEN THE MEDIAL CUNEIFORM AND THE NAVICULAR BONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501596 ↗
• InjuryDec 4, 2019Fracture; Fracture

  DURING A ROUTINE FOLLOW UP VISIT, IT WAS DISCOVERED THE CLIP WAS BROKEN BUT THE JOINT HAD REMAINED FUSED. THE DOCTOR REMOVED THE CLIP (B)(6) 2018 AND DID NOT PLACE ADDITIONAL HARDWARE AS THE PATIENT HAS EXPERIENCED PROPER FUSION.

  Patient problems: Failure of Implant

  MAUDE report 9410916 ↗