UNIVER TOFFLEMIRE TYPE RE
Received Oct 18, 2016
Report 2523190-2016-00168 · MDR key 6036495
Device
Product problems
- Material Protrusion/Extrusion
- Material Protrusion/Extrusion
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON OCTOBER 12, 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: EVALUATION OF RETURNED DEVICE; THERE WERE TEN TOFFLEMIRE RETAINERS RETURNED WITH NO UNUSUAL MARKINGS AND COMPLAINT STATING THAT THE DOCTOR CUT HIMSELF. UPON FURTHER INVESTIGATION IT IS FOUND THAT MOST DO HAVE SHARP EDGES ON THEM. DHR REVIEW; THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY COMPLAINTS HISTORY; COMPLAINT METRICS TRACKED, TRENDED, AND REVIEWED MONTHLY WITH MANAGEMENT. CONCLUSION: THE COMPLAINT REPORT IS CONFIRMED; THE ROOT CAUSE HAS BEEN DETERMINED TO BE A WORKMANSHIP OR MATERIAL DEFICIENCY. APPROPRIATE ACTION HAS BEEN IMPLEMENTED TO RECTIFY THIS MANUFACTURING DEFICIENCY.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS DEVICE DEFECTIVE CUTS DOCTORS HAND. ON 9/30/2016 DOCTOR REPORTS SHE WAS APPLYING A BAND TO A LOWER R BACK MOLAR WHEN SHE WAS CUT ON SHARP THREADS OF THE DEVICE. NO SPECIAL TREATMENT NECESSARY, NO INFECTION. NO HARM TO PATIENT