FDA Adverse Event Injury Summary report: N

MEDPOR IMPLANT

MDR report key: 1820554 · Received August 26, 2010

Report

Report Number: 1057129-2010-00020
Event Type: Injury
Date Received: August 26, 2010
Date of Event: October 1, 2008
Report Date: August 24, 2010
Manufacturer: POREX SURGICAL
Product Code: FTM
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORD FOR LOT NUMBER MCI-322-07-C001M132H WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT SPECIFICATIONS.

Description of Event or Problem · 1

THE PT CONTACTED A POREX SURGICAL DISTRIBUTOR AND STATED THAT HE UNDERWENT SURGERY IN (B)(6) 2006 DUE TO A HEAD INJURY AND AN ACUTE SUBDURAL HEMATOMA. THE PT STATED THAT IN (B)(6) 2007, THE RIGHT SECTION OF HIS SKULL BONE WAS REMOVED BECAUSE OF AN INFECTION AROUND THE WOUND. THE PT STATED THAT IN (B)(6) 2008, HE RECEIVED A MEDPOR RIGHT CRANIAL IMPLANT ON THE RIGHT SIDE OF HIS SKULL. THE PT STATED THAT AROUND (B)(6) 2008, A REDDENING OF THE SKIN ON THE IMPLANT AND ON THE FOREHEAD AREA OCCURRED AND REMAINED FOR TWO DAYS. THE PT SATED THAT THIS OCCURRED RANDOMLY SINCE (B)(6) 2008 AND THREE PERMANENT DARK PURPLE SPOTS REMAIN ON THE SKIN. THE PT STATED THAT IN (B)(6) 2010, THE REDDENING OCCURRED AND LASTED AROUND 10 DAYS. THE PT STATED THAT HIS NEUROSURGEON, PLASTIC SURGEON AND TWO DIFFERENT DERMATOLOGISTS COULD NOT DIAGNOSE THE SITUATION. THE PT REPORTED THAT HIS "NEUROLOGIST SAID THAT THE PAIN HAS NOTHING TO DO WITH THE IMPLANT BUT RATHER IT IS MOST LIKELY AN INFLAMMATION OF THE NERVE ENDING ON THE SKIN LEVEL". THE PT STATED THAT HE IS DOING "PRETTY GOOD".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MEDPOR IMPLANT	MEDPOR PREFORMED CRANFACIAL SHAPES	FTM	POREX SURGICAL	NA	MCI-32207C001M132H

Patients

Seq	Age	Sex	Outcome	Treatment
1	34 YR		Other