DynaFORCERecalls & reported problems across all models
Crossroads Extremity Systems · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 8 models of DynaFORCE by Crossroads Extremity Systems in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2019 and Sep 6, 2024 — classified as 7 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Fracture” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DynaFORCE problems
Device problems
- Fracture16
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Failure of Implant3
- No Code Available2
- Hypersensitivity/Allergic reaction1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
- Swelling1
DynaFORCE models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DynaFORCE™ 7118-1818KTStaple, Fixation, Bone6 reports
- DynaFORCE™ 7115-1515KTStaple, Fixation, Bone5 reports
- DynaFORCE™ 7009-0909KTStaple, Fixation, Bone3 reports
- DynaFORCE™ 7120-2020KTStaple, Fixation, Bone2 reports
- DynaForce gSource H8 Retaining DriverDriver, Prosthesis1 report
- DynaFORCE™ 7012-1212KTStaple, Fixation, Bone1 report
- DynaFORCE™ 7118-1414KTStaple, Fixation, Bone1 report
- DynaFORCE™ 7125-2222KTStaple, Fixation, Bone1 report
Recent DynaFORCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AUGUST 13, 2024 THE T8 SCREWDRIVER SHAFT HAD BEEN STRIPPED DURING HARDWARE REMOVAL AND WAS UNUSABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A GSOURCE H8 RETAINING DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20162079 ↗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 ↗MalfunctionOct 14, 2022Fracture; Fracture
DOCTOR MENTIONED THAT HE HAD A CASE IN WHICH SOME OF THE HARDWARE EXPERIENCED MECHANICAL FAILURE. THE DISCOVERY DATE OF THE HARDWARE IS UNKNOWN. AN EMAIL WAS SENT TO THE SURGICAL REPRESENTATIVE TO FIND OUT MORE INFORMATION REGARDING THE FAILURE. AN X-RAY WAS OBTAINED AND WILL BE INCLUDED IN THE COMPLAINT FILE. THE X-RAY DEPICTS WHAT APPEARS TO BE A BROKEN HIMAX IMPLANT ALONG WITH 2 BROKEN SCREWS. THE ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2018. THE HARDWARE WAS NOT REMOVED OR REVISED AND THERE ARE NO PLANS TO REVISE THE SITE. PER THE SALES REP, DOCTOR IS SATISFIED WITH THE OUTCOME OF THE CASE AND THE STATUS OF THE UNION. REP ALSO MENTIONED THAT THE PATIENT WAS NON-COMPLIANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15606518 ↗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 MIDFOOT AND SUBTALAR FUSION CASE. HE USED CROSSROADS STAPLES IN THE MIDFOOT TO FUSE THE MEDIAL AND INTERMEDIATE CUNEIFORMS TO A NAVICULAR GRAFT FROM THE ILIAC CREST THAT WAS HARVESTED IN THE SAME SURGERY. THIS PATIENT HAD MUELLER WEISS SYNDROME WHICH IS AN ADULT ONSET OSTEONECROSIS OF THE TARSAL NAVICULAR. AT SOME POINT POST-OPERATION ONE OF THE CLIP LEGS BROKE IN THE PATIENT. DOCTOR SAYS THE BONES EVENTUALLY FUSED EVEN THOUGH ONE OF THE CLIP LEGS WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501693 ↗MalfunctionSep 29, 2022Fracture; Fracture
DOCTOR REPORTS THAT ON (B)(6) 2019 HE PERFORMED A 1ST, 2ND, AND 3RD TARSO-METATARSAL FUSION SURGERY USING CROSSROADS STAPLES FOR THE 2ND AND 3RD TMT FUSIONS. HE SAYS THAT AT SOME POINT POST-SURGERY THE PROXIMAL STAPLE LEG IN THE 3RD TMT JOINT BROKE. DOCTOR REPORTS THAT THE PATIENT IS A SMOKER AND IS ALSO NON-COMPLIANT WITH REGARDS TO WEIGHTBEARING. HOWEVER, HE SAYS ON THE OBLIQUE X-RAY PROVIDED THAT THE JOINTS APPEAR TO BE HEALING WELL AND FUSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501686 ↗MalfunctionSep 29, 2022Fracture; Fracture
THIS COMPLAINT WAS RECEIVED BY MAIL THROUGH AN FDA MEDICAL DEVICE REPORT (MDR) THAT WAS WRITTEN BY A PATIENT. ALLEGEDLY, THE PATIENT STATES THAT THEY HAVE A DEFECTIVE AND BROKEN CLIP THAT HAS CAUSED LIMPING, BACK MISALIGNMENT AND KNEE PAIN. THE PATIENT IS CONVINCED THE CLIP WAS BROKEN AND DEFECTIVE AT THE TIME OF IMPLANTATION, ACCORDING TO THE REPORT (MW5086568).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501680 ↗MalfunctionSep 29, 2022Fracture; Fracture
DOCTOR PERFORMED ROUTINE FOLLOW-UP X-RAY POST-OPERATIVELY AFTER AKIN PROCEDURE. DOCTOR IDENTIFIED THAT THE 9MM X 9MM X 9MM CLIP WAS BROKEN. REFER TO POST-OPERATIVE X-RAY FOR CLIP BROKEN ACROSS THE BRIDGE. HE DOES NOT PLAN A REVISION AS THE PATIENT IS ASYMPTOMATIC. CONSERVATIVE CARE WILL CONTINUE UNTIL FUSION OCCURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501600 ↗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 ↗MalfunctionSep 29, 2022Fracture; Fracture
REP REPORTS THAT DOCTOR PERFORMED A 2ND AND 3RD TMT FUSION CASE WITH 4 CLIPS. UPON FOLLOW-UP POST-PROCEDURE, THE MOST MEDIAL CLIP ON THE 2ND TMT FUSION APPEARED BROKEN ON X-RAY WHICH WAS ONE OF THE THREE 18MM X 18MM HIMAX IMPLANTS USED IN THE CASE. REP REPORTS THAT THE PATIENT IS DOING FINE AND THE JOINT HAS EXPERIENCED PROPER FUSION. NO REVISION SURGERY IS PLANNED TO DATE. NO RESOLUTION. PATIENT IS REPORTED TO BE DOING OKAY AND JOINT IS PROPERLY FUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501585 ↗MalfunctionSep 29, 2022Fracture; Fracture
DOCTOR IMPLANTED A 20 MM DYNAFORCE CLIP ACROSS AN ALLOGRAFT WEDGE IN ORDER TO PROMOTE FUSION. DURING A ROUTINE FOLLOW UP VISIT, DOCTOR DISCOVERED THAT THE IMPLANT HAD FRACTURED IN BOTH LEGS. HE ALSO STATED THE ALLOGRAFT SEEMED TO BE EXPERIENCING FUSION. HOWEVER, HE WAS NOT CONFIDENT IN THE EXTENT OF THE FUSION. HE PLANS TO MONITOR THE PATIENT AND SEE IF THE JOINT CONTINUES TO EXHIBIT FUSION. DOCTOR DOES NOT CURRENTLY HAVE ANY PLANS TO REVISE OR EXPLANT THE HARDWARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501491 ↗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 ↗InjuryDec 4, 2019Fracture; Fracture
NINE (9) MONTHS POST-OP BROKEN CLIP AND PLATE WERE IDENTIFIED. REVISION SURGERY WAS SCHEDULED FOR HARDWARE REMOVAL. THE DOCTOR CONFIRMED FUSION VIA X-RAY AND WILL NOT PLACE ADDITIONAL HARDWARE AFTER REMOVAL.
Patient problems: Failure of Implant
MAUDE report 9410446 ↗
Other Crossroads Extremity Systems products
All Crossroads Extremity Systems devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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