NEXGEN 00507120100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10845854004982), received between Mar 27, 2023 and Jul 1, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 00507120100, NEXGEN OSCILLATOR BLADE WAS BEING USED ON (B)(6) 2024 DURING A PTA PROCEDURE WHEN IT WAS REPORTED ¿DURING PTG PROCEDURE THE BLADE BREAKS WHERE IT ENGAGES .¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS REMOVED WITH THE USE OF A VACUUM. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BLADE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650164 ↗
• MalfunctionJul 1, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 00507120100, NEXGEN OSCILLATOR BLADE WAS BEING USED ON 06JUN24 DURING A PTA PROCEDURE WHEN IT WAS REPORTED ¿BLADE TOOTH BREAKS. USED RX TO FIND BLADE RESIDUE IN JOINT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS REMOVED WITH THE USE OF A VACUUM. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BLADE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650093 ↗
• MalfunctionJul 10, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 00507120100, NEXGEN OSCILLATOR BLADE, WAS BEING USED DURING A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023 WHEN IT WAS REPORTED ¿CORNER TOOTH BROKE OFF.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS RETRIEVED WITH THE USE OF A FORCEP.¿. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288761 ↗
• MalfunctionMar 27, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 00507120100, NEXGEN OSCILLATOR BLADE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿TEETH BLADE BROKE OFF ¿ NURSE LOOKED AND WAS ABLE TO FIND THE PIECE. NO IMPACT TO THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER. FURTHER ASSESSMENT QUESTIONS HAVE BEEN SENT TO THE REPORTER; HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. FRAGMENTATION IS REPORTED AS HAVING BEEN FOUND AND WE HAVE NOT RECEIVED ANY NOTIFICATION THAT FRAGMENTATION WAS LEFT IN THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617422 ↗