FDA Adverse Event Injury Summary report: N

WASHER 13.0MM

MDR report key: 2842154 · Received November 21, 2012

Report

Report Number: 8030965-2012-01316
Event Type: Injury
Date Received: November 21, 2012
Report Date: October 25, 2012
Manufacturer: SYNTHES GMBH
Product Code: HTN
PMA / PMN Number: PREAMEND
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT. 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.

Description of Event or Problem · 1

CONSULTANT REPORTS TWO PROCEDURES PERFORMED ON ONE SURGERY. PATIENT IMPLANTED ON UNKNOWN DATE WITH TWO SCREWS AND TWO WASHERS ON TIBIA PLATEAU. PATIENT ALSO IMPLANTED WITH LCP ONE THIRD TUBULAR PLATE, SIX SCREWS, AND ONE MALLEOLAR SCREW. IT IS UNKNOWN WHICH CONSTRUCT WAS IMPLANTED FIRST. PATIENT COMPLAINED OF IRRITATION AND REQUESTED REMOVAL OF ALL HARDWARE. PATIENT WAS RETURNED TO OR ON (B)(6) 2012. FIRST PROCEDURE WAS REMOVAL OF THE SCREWS FROM THE TIBIA PLATEAU. HARDWARE APPEARED INTACT, FRACTURE APPEARED HEALED. SURGEON THEN REMOVED THE LCP ONE THIRD TUBULAR PLATE AND ALL SCREWS. THIS CONSTRUCT ALSO APPEARED INTACT AND FRACTURE APPEARED HEALED. THIS IS 4 OF 12 REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	WASHER 13.0MM	WASHER	HTN	SYNTHES GMBH

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention	SCREW, WASHER, PLATE