FDA Adverse Event Injury Summary report: N

UNKNOWN LOCK SCREW

MDR report key: 3850495 · Received June 5, 2014

Report

Report Number: 0001825034-2014-05222
Event Type: Injury
Date Received: June 5, 2014
Date of Event: May 7, 2014
Report Date: May 10, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: LXT
PMA / PMN Number: PK112345
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO EVENT DETAILS AND PRODUCT IDENTIFICATION ARE IN PROCESS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. CATEGORY NUMBER - 131227112 OR 131227114 OR 131227116 OR 131227118 OR 131227120. LOT NUMBER AND EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05221 / 05222).

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION, INTERNAL FIXATION PROCEDURE ON (B)(6) 2014 DUE TO LEFT DISTAL RADIUS FRACTURE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN AND INSTABILITY. IT WAS DISCOVERED THAT THE PROXIMAL SCREWS OF THE DVR CROSSLOCK DISTAL RADIUS PLATING SYSTEM HAD BACK OUT. THE SURGEON STATED IT APPEARED THE SELECTED PLATE WAS NOT LONG ENOUGH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
328650	UNKNOWN LOCK SCREW	APPLIANCE, FIXATION	LXT	BIOMET ORTHOPEDICS	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R