FDA Adverse Event Injury Summary report: N

2520274-2013-11167

MDR report key: 3905857 · Received November 2, 2013

Report

Report Number: 2520274-2013-11167
Event Type: Injury
Date Received: November 2, 2013
Report Date: January 10, 2007
Manufacturer: SYNTHES (USA)
Product Code: KWQ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

Description of Event or Problem · 1

PATIENT PARTICIPATED IN A MULTI-CENTER, 4-ARM STUDY AT VERTEBRAL LEVELS 1,2,3 OR 4 TO EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES IN PATIENTS DIAGNOSED WITH CERVICAL DEGENERATIVE DISK DISEASE (DD) BETWEEN C2-C7, PATIENT WAS IMPLANTED WITH A VECTRA-T CERVICAL PLATE AND A CORICO CANCELLOUS ANTERIOR CERVICAL FUSION (CC ACF) SPACER AT LEVELS C5, C6 AND C7 WITH PEDICLE SCREWS AT C5, C6, AND C7. POSTOPERATIVELY, PATIENT EXPERIENCED HEMATOMA/SEROMA, REQUIRING SURGERY TO REMOVE HEMATOMA WITH NO FURTHER COMPLICATIONS. THIS COMPLAINT IS ON THE RIGHT 16MM FIXED ANGLE SCREW AT C5. THIS IS REPORT 3 OF 7 FOR THIS EVENT. THIS REPORT IS FOR FILE (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
565908			KWQ	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention