DynaFORCE™ 7009-0909KTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815432023288), received between Mar 26, 2019 and Sep 29, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K142727, K181410); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 27, 2019Fracture; Fracture

  LAPIDUS PROCEDURE WAS PERFORMED ON (B)(6) 2018. IN FOLLOW-UP, DOCTOR REPORTS PARTIAL FUSION OF JOINT IN ADDITIONAL TO BREAKAGE OF THE HARDWARE - NAMELY 1 LOCKING SCREW AND 1 LEG OF A NITINOL CLIP. PATIENT HAS POST-OPERATION PAIN AND SWELLING. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO REMOVE HARDWARE.

  Patient problems: Pain; Swelling

  MAUDE report 8458320 ↗
• MalfunctionMar 26, 2019Fracture; Fracture

  DATE OF INITIAL SURGERY IS (B)(6) 2017. THE DOCTOR IMPLANTED TWO 9MM DYNAFORCE IMPLANTS DORSALLY ACCROSS THE FIRST IPJ. AT 4 WEEK ROUTINE POST-OP VISIT THE DOCTOR DISCOVERED 1 FRACTURED IMPLANT AND NON-UNION OF FUSION SITE. DOCTOR PLANS TO CONTINUE TO MONITOR PATIENT AND UPDATE US IF A REVISION SURGERY IS PERFORMED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8453804 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142727, K181410. One submission often covers many models, so check the product and lot details in each record.

• Z-1487-2017 · Feb 16, 2017 · Terminated
  MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.