FDA Adverse Event Other Summary report: N

NUOSS

MDR report key: 2591898 · Received May 18, 2012

Report

Report Number
2249852-2012-00002
Event Type
Other
Date Received
May 18, 2012
Date of Event
August 18, 2012
Report Date
March 10, 2012
Manufacturer
COLLAGEN MATRIX, INC.
Product Code
NPM
PMA / PMN Number
K043034
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

INFECTION. EXTRACTION SOCKET REGRAFTED AFTER DEBRIDEMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NUOSS ANORGANIC BONE MINERAL NPM COLLAGEN MATRIX, INC. BMC2510 BMCU08C5

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention