FDA Adverse Event Malfunction Summary report: N

4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM

MDR report key: 2973584 · Received February 22, 2013

Report

Report Number: 2520274-2013-01122
Event Type: Malfunction
Date Received: February 22, 2013
Report Date: January 25, 2013
Manufacturer: SYNTHES (USA)
Product Code: KWQ
PMA / PMN Number: K031276
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION AND DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED.

Description of Event or Problem · 1

A REPORT WAS RECEIVED REGARDING A PATIENT IMPLANTED WITH A 2-LEVEL CSLP PLATE, 6 LOCKING SCREWS AND 6 SELF TAPPING EXPANSION SCREWS, DATE UNSPECIFIED. REPORTEDLY, IT WAS REVEALED THROUGH RADIOGRAPHIC IMAGING THAT THE PLATE AND TWO SCREWS WERE BROKEN. SUBSEQUENTLY, ON (B)(6) 2013, THE PATIENT RETURNED TO THE OR FOR REMOVAL OF ONE PLATE AND 6 LOCKING SCREWS AND 6 SELF TAPPING EXPANSION SCREWS. UPON REMOVAL, SEVERAL OF THE FLANGES FROM THE TOPS OF THE SCREWS ALSO CAME OUT, REPORTED AS SEPARATED FROM THE SCREW HEAD. AT LEAST TWO OF THE SCREWS HAD FLANGES DAMAGE AT THE TIME OF THIS REPORT. ADDITIONALLY, THE X-RAY REVEALS AT LEAST TWO BROKEN SCREWS. IT WAS REPORTED THAT AT LEAST ONE FRAGMENT OF A SCREW REMAINED IMPLANTED. IT WAS REPORTED THAT THE ANTICIPATED TREATMENT IS TO REVISE THE PATIENT WITH A NEW PLATE AND PEEK SPACER, NO DATE SPECIFIED. THIS IS REPORT NUMBER 3 OF 5 FOR THE SAME EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
78099	4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM	CORTEX EXPANSIONHEAD SCREW	KWQ	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention