MotoBAND Implant, 3.5mm x 36mm Anti-Drift BoltRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815432028825), received between Jun 7, 2021 and Sep 29, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Migration” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  THE SURGEON REPORTED ON (B)(6) 2021 THAT THE PATIENT'S ADB BACKED OUT. THE PATIENT IS ASYMPTOMATIC, AND NO REVISION IS PLANNED. X-RAY ON (B)(6) 2021 SHOWS THAT THE ADB HEAD IS PROMINENT ABOVE THE PLATE. THE TIP OF THE ADB IS IN THE 2ND METATARSAL BASE AND NOT THE LATERAL CORTEX OF THE 2ND METATARSAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501698 ↗
• MalfunctionSep 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATES THAT THE SURGEON HAS 2 DYNABUNION PATIENTS ((B)(6)) UNDERGOING EVALUATION FOR POTENTIAL NON-UNIONS. THE INVESTIGATOR CONTACTED THE SURGEON TO RETRIEVE MORE INFORMATION RELATED TO THE ALLEGED COMPLAINT AND HAS NOT RECEIVED A REPLY. PART NUMBERS, LOT NUMBERS, AND FINAL PROGNOSIS IS UNKNOWN AT THIS TIME. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME. IT IS UNKNOWN IF PATIENTS EXPERIENCED NON-UNION; THUS, THE COMPLAINT HAS NOT BEEN CONFIRMED.

  Patient problems: Malunion of Bone

  MAUDE report 15501617 ↗
• MalfunctionSep 29, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATES THAT THE SURGEON HAS 2 DYNABUNION PATIENTS (PC 0239 AND PC 0240) UNDERGOING EVALUATION FOR POTENTIAL NON-UNIONS. THE INVESTIGATOR CONTACTED THE SURGEON TO RETRIEVE MORE INFORMATION RELATED TO THE ALLEGED COMPLAINT AND HAS NOT RECEIVED A REPLY. PART NUMBERS, LOT NUMBERS, AND FINAL PROGNOSIS IS UNKNOWN AT THIS TIME. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME. IT IS UNKNOWN IF PATIENTS EXPERIENCED NON-UNION; THUS, THE COMPLAINT HAS NOT BEEN CONFIRMED.

  Patient problems: Malunion of Bone

  MAUDE report 15501563 ↗
• MalfunctionSep 29, 2022Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  THE DYNABUNION SYSTEM WITH ANTI-DRIFT BOLT WAS IMPLANTED (B)(6) 2021. APPROXIMATELY 3 MONTHS LATER AFTER ROUTINE FOLLOW-UP, THE SALES REPRESENTATIVE REPORTED THAT THE ANTI-DRIFT BOLT BACKED OUT. THE REPRESENTATIVE DID NOT REPORT THAT THE ABD WAS REMOVED. THE REPRESENTATIVE DID NOT REPORT THAT THE PATIENT HAD CLINICAL SYMPTOMS SUCH AS PAIN ASSOCIATED WITH THE ANTI-DRIFT BOLT BACK-OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501551 ↗
• MalfunctionJun 7, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE SURGEON REPORTED THAT THE PATIENT'S ANTI-DRIFT BOLT (ADB) BACKED OUT. THE PATIENT ORIGINALLY HAD LAPIDUS SURGERY WITH DYNABUNION PLATE AND ADB ON (B)(6) 2020. THE PATIENT ALSO HAD A TALONAVICULAR FUSION WITH CROSSROADS STAPLES, PLATES AND SCREWS. THE ADB WAS REPLACED WITH ANOTHER SCREW ON (B)(6) 2021. OTHER HARDWARE WAS NOT REVISED.

  Patient problems: Pain

  MAUDE report 11952200 ↗