FLANGE FIXTURE AND ABUTMENT

MDR report key: 2902351 · Received January 8, 2013

Report

Report Number: 6000034-2013-00048
Event Type: Injury
Date Received: January 8, 2013
Date of Event: December 27, 2012
Report Date: April 12, 2013
Manufacturer: COCHLEAR BONE ANCHORED SOLUTIONS AB
Product Code: LXB
PMA / PMN Number: K955713
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: AUDIOLOGIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). IMPLANTED DEVICE REMAINS.

Additional Manufacturer Narrative · 1

CORRECTION: THE CORRECT PATIENT IDENTIFIER IS (B)(6); NOT (B)(6) AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT CATALOG NUMBER IS 922346; NOT 92127 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

Description of Event or Problem · 1

PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2012 RESULTING IN FIXTURE LOSS. THERE ARE PLANS TO REPLACE THE LOST FIXTURE, BUT IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
8977	FLANGE FIXTURE AND ABUTMENT	LXB	LXB	COCHLEAR BONE ANCHORED SOLUTIONS AB	N/A	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Required Intervention