2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM

MDR report key: 2251111 · Received September 13, 2011

Report

Report Number: 1719045-2011-00569
Event Type: Injury
Date Received: September 13, 2011
Date of Event: August 16, 2011
Report Date: August 16, 2011
Manufacturer: SYNTHES MONUMENT
Product Code: JEY
PMA / PMN Number: K063790
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RETURNED.

Description of Event or Problem · 1

DURING A HIGH-RAMUS FRACTURE REDUCTION PROCEDURE OF MANDIBLE, THE SURGEON POSITIONED THE MATRIXMANDIBLE PLATE AND INSERTED ONE LOCKING SCREW. THE SCREW HELD TO BEGIN WITH, THEN WENT THROUGH THE PLATE. THE SURGEON TRIED A SECOND LOCKING SCREW, DRILLED AND INSERTED THE SCREW, AND WHEN HE CHECKED IT FOR TIGHTNESS, IT ALSO PULLED THROUGH THE PLATE. HE THEN REMOVED THE PLATE AND SCREWS, AND TRIED MANUALLY PLACING THE LOCKING SCREWS IN THE PLATE (OUTSIDE THE PT), AND THE SCREWS WENT RIGHT THROUGH. THE SURGEON THEN SELECTED A SECOND PLATE AND MANUALLY TRIED THE LOCKING SCREWS OUTSIDE THE PT, WHICH ALSO WENT RIGHT THROUGH THE PLATE. THE SURGEON THEN SELECTED 2.0 NON-LOCKING SCREWS, AND REPOSITIONED THE SECOND MATRIXMANDIBLE PLATE, WHICH HELD SECURELY WITHOUT PULLING THROUGH. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE USING THE 2.0 NON-LOCKING SCREWS. APPROX 1 HOUR AND 15 MINUTES WAS ADDED TO THE PROCEDURE TIME. THIS IS TWO OF THREE REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM	TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG	JEY	SYNTHES MONUMENT

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR			DCP PLATE