FDA Adverse Event Injury Summary report: N

CASPIAN

MDR report key: 2940615 · Received January 30, 2013

Report

Report Number: 3004774118-2013-00003
Event Type: Injury
Date Received: January 30, 2013
Date of Event: January 16, 2013
Report Date: January 30, 2013
Manufacturer: K2M, INC.
Product Code: MNH
PMA / PMN Number: K092640
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE SCREW WAS RECENTLY RECEIVED AND WILL BE SENT TO AN INDEPENDENT LABORATORY FOR ANALYSIS. THE MANUFACTURING AND INSPECTION RECORDS FOR THE SCREW WERE REVIEWED AND NO DISCREPANCIES WERE NOTED - THE SCREW WAS MANUFACTURED ACCORDING TO SPECIFICATION. IT IS WORTH NOTING HOWEVER, THAT THE SCREW THAT BROKE IS A SMALL SCREW, INDICATED FOR CERVICAL THORACO FIXATION AND IT WAS USED AT L3. IT WAS THE DISTAL MOST SCREW IN THE CONSTRUCT. THE SURGEON REPLACED THE SCREW AT L3 AND EXTENDED THE CONSTRUCT ANOTHER LEVEL DOWN. THE SURGEON WAS PLEASED WITH THE OUTCOME AS EXCELLENT CORRECTION WAS ACHIEVED AND THE CONSTRUCT BELIEVED TO BE STRONG. THE SURGEON HAS BEEN CONTACTED TO SEE IF THERE WERE POSSIBLY ANY OTHER CONTRIBUTORY FACTORS. NO FIRM CONCLUSION CAN BE MADE UNTIL FEEDBACK FROM THE SURGEON IS OBTAINED AND THE ANALYSIS OF THE PART IS COMPLETED.

Additional Manufacturer Narrative · 1

PART ANALYSIS SHOWED FRACTURE SURFACE (BREACH MARKS ON ONE SIDE) INDICATING UNIDIRECTIONAL FATIGUE OVERLOAD. NO MATERIAL OR MANUFACTURING DEFECTS OBSERVED. MANUFACTURER IS NOT EXPECTING ADDITIONAL INFORMATION AND CONSIDERS THIS TO BE A CLOSING REPORT.

Description of Event or Problem · 1

MINI MESA SCREW BROKE APPROXIMATELY 3 MONTHS POST-OPERATIVELY. THE PT WAS REVISED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
41550	CASPIAN	PEDICLE SCREW	MNH	K2M, INC.		AUGD

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention