InjuryNDF
*
Received Dec 24, 2002 · Event occurred Nov 19, 2002
Report 434953 · MDR key 434953
Device
Generic name
Mandibular Plate - Level One
Manufacturer
Kls MartinModel number
*Catalog number
*
Lot number
UNK
Product problems
- Break
Patient
85 YR
- Abscess
- Unspecified Infection
- Surgical procedure, repeated
Narrative
Description of Event or Problem
PT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT IN 09/02. PT WAS TAKEN TO SURGERY FOR AN OPEN REDUCTION AND INTERNAL FIXATION OF COMMINUTED RIGHT AND LEFT FRACTURE OF THE MANDIBULAR BODY. PT WAS RETURNED TO THE OR FOR INCISION AND DRAINAGE OF LEFT MANDIBULAR ABSCESS AND REMOVAL OF BROKEN MANDIBULAR FIXATION PLATES. PER THE PHYSICIAN, THE PT HAD SOFT BONES THAT WOULDN'T BREAK THE PLATE, AND HE FEELS THE PROBLEM WAS WITH THE PLATE ITSELF. TWO KLS REPS WERE PRESENT FOR FIRST SURGERY. PT EXPIRED 16 DAYS LATER AFTER CARDIAC ARREST.