FDA Adverse Event Injury Summary report: N

SCREW, FIXATION, BONE

MDR report key: 4356189 · Received December 23, 2014

Report

Report Number: 2520274-2014-15538
Event Type: Injury
Date Received: December 23, 2014
Date of Event: June 11, 2013
Report Date: December 3, 2014
Manufacturer: SYNTHES USA
Product Code: DZL
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN MATRIXNEURO SCREW/UNKNOWN QUANTITY/UNKNOWN LOT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, "SCALP NECROSIS FOLLOWING PEROPERATIVE EMBOLIZATION FOR MENINGEAL TUMORS: TWO CAUTIONARY TALES" (2013). KIRKMAN, M.A., SETHI, H., & KITCHEN, N.D. ACTA NEUROCHIR, 15, 1413-1415. A REPORT WAS DONE ON PREOPERATIVE EMBOLIZATION FOR MENINGEAL TUMORS. IN THE REPORT A (B)(6) FEMALE DEVELOPED NECROSIS AFTER A CRANIOTOMY THAT HEALED POORLY AND HAD SEROUS DISCHARGE FOR SEVERAL MONTHS. IN TWO AREAS OF THE NECROSIS THERE WAS A SYNTHES MATRIXNEURO PLATE AND SCREW PROTRUDING POSTERIORLY AND A SYNTHES MATRIXNEURO SCREW PROTRUDING ANTERIORLY. THE SYNTHES MATRIXNEURO PLATE AND SCREWS WERE SUBSEQUENTLY EXPLANTED. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT IS FOR 1 UNKNOWN MATRIXNEURO SCREW.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
846975		SCREW, FIXATION, BONE	DZL	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention