OsteoMed 450-0241Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00845694037167), received between Sep 25, 2019 and Sep 19, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THEY USED THE SAW FOR THE FIRST CASE AFTER RECEIVING IT, THE HANDPIECE WAS COMPLETELY BROKEN. NO DELAY OR ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098028 ↗
• MalfunctionAug 6, 2024Mechanical Problem; Mechanical Problem

  DURING REVIEW OF THE SERVICE AND REPAIR ORDER (SRO) LOG, IT WAS NOTED THE DEVICE EVACUATION/DIAGNOSIS STATED "WHEN RUNNING AT 75% SPEED AS RECOMMENDED, THE SAW BLADE WILL BE LOOSENED AND FINALLY EJECTED FROM THE HANDPIECE". FOLLOW UP WAS CONDUCTED BY THE CUSTOMER WHO REPORTED THIS ISSUE OCCURRED DURING A SURGERY. ADDITIONAL INFORMATION PROVIDED INDICATED THE SAW BLADE KEPT LOOSENING FROM THE HANDPIECE BUT WOULD STILL "GET THE JOB DONE" ALTHOUGH THEY HAD TO KEEP PUSHING THE BLADE IN THE HANDPIECE. THE SURGERY WAS NOT PROLONGED, AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918756 ↗
• MalfunctionJan 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE, THE SAW BROKE JUST BELOW THE BLACK PART OF THE SAW. NO PATIENT HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13242771 ↗
• MalfunctionJan 12, 2022Temperature Problem; Temperature Problem

  ON 18 AUGUST 2020, THE FACILITY OFFICE MANAGER REPORTED THEY HAD TWO MACHINES THAT WERE GETTING HOT AND BURNING THE MUCOSA IN THE PATIENT'S MOUTHS. IT WAS REPORTED THERE WAS NO PATIENT HARM, AND NO TREATMENT OR MEDICAL INTEVENTION WAS NECESSARY AS A RESULT OF THE BURNS. THIS REPORT IS FOR ONE OF THE DEVICES ASSOCIATED WITH COMPLAINT (B)(4).

  Patient problems: Burn(s)

  MAUDE report 13242769 ↗
• MalfunctionJan 12, 2022Temperature Problem; Temperature Problem

  ON (B)(6) 2020, THE FACILITY OFFICE MANAGER REPORTED THEY HAD TWO MACHINES THAT WERE GETTING HOT AND BURNING THE MUCOSA IN THE PATIENT'S MOUTHS. IT WAS REPORTED THERE WAS NO PATIENT HARM, AND NO TREATMENT OR MEDICAL INTERVENTION WAS NECESSARY AS A RESULT OF THE BURNS. THIS REPORT IS FOR ONE OF THE DEVICES ASSOCIATED WITH COMPLAINT (B)(4).

  Patient problems: Burn(s)

  MAUDE report 13242273 ↗
• MalfunctionJan 12, 2022Temperature Problem; Temperature Problem

  ON (B)(6) 2020, PERSONNEL FROM DR. GUYETTE'S OFFICE CALLED OSTEOMED SR. PRODUCT MANAGER ASKING ABOUT SUGGESTED MAINTENANCE SCHEDULE FOR THE RECIPROCATING SAW. THE CALLER ASKED IF THE RECIPROCATING SAW REQUIRED LUBRICATION SIMILAR TO THAT OF THE DRILL AND REPORTED THE SAW WAS USED SELDOMLY, AND MOST LIKELY HAD NEVER BEEN LUBRICATED, TO THE BEST OF HER KNOWLEDGE. THE CALLER STATED THE SURGEON HAD USED THE SAW RECENTLY, AND NOTED THE SAW HAD GOTTEN HOT DURING USE, RESULTING IN AN "INSIGNIFICANT" BURN TO THE PATIENT BURNED DURING THE PROCEDURE. IT WAS RECOMMENDED TO THE CALLER TO NO LONGER USE THE SAW AND RETURN TO OSTEOMED FOR EVALUATION, SERVICE, AND/OR REPAIR. INFORMAITON OBTAINED DURING FOLLOW UP REGARDING THE BURN WAS THAT THE DEGREE OF BURN WAS "INSIGNIFICANT". NO FURTHER INFORMAITON COULD BE OBTAINED.

  Patient problems: Burn(s)

  MAUDE report 13242270 ↗
• MalfunctionJan 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 20 JULY 2019, THE SURGEON WAS USING THE RECEIPROCATING SAW TO CUT THE MANDIBLE WITH A 451-2015-SP BLADE. AS HE WAS CUTTING THE MANDIBLE, THE SAW HEAD BROKE OFF. NO INJURY OR ADVERSE HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13242267 ↗
• MalfunctionJan 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 04 JUNE 2019, CUSTOMER SERVICE WAS NOTIFIED THAT "A PIECE OF INSTRUMENTAL BROKE IN SURGERY", AND A PHOTOGRAPH OF THE DAMAGED SAW WAS PROVIDED. FOLLOW UP ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION REGARDING THE EVENT AND THE PATIENT TO NO AVAIL.

  Patient problems: Insufficient Information

  MAUDE report 13242266 ↗
• MalfunctionSep 25, 2019Break; Material Too Rigid or Stiff; Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THE DISTRIBUTOR CONTACTED OSTEOMED CONCERNING AN ADVERSE EVENT. PER THE COMPLAINT, THE RECIPROCATING SAW BURNED/CAUSED ABRASION ON PATIENT'S LIP/FACE. THE QUICK DETACH BLACK COLLAR RUBBED (POSSIBLY AN INSTRUMENT) AND STARTED TO DISINTEGRATE LEAVING ROUGH EDGES WHICH THEN CAUSED THE INJURY DURING ORTHOGNATHIC SURGERY.

  Patient problems: Abrasion; Burn(s); Burn, Thermal

  MAUDE report 9119485 ↗