FDA Adverse Event Other Summary report: N

LORENZ PECTUS SUPPORT BAR, 14IN

MDR report key: 927925 · Received October 4, 2007

Report

Report Number
1032347-2007-00025
Event Type
Other
Date Received
October 4, 2007
Report Date
September 21, 2007
Manufacturer
BIOMET MICROFIXATION, INC.
Product Code
HRS
PMA / PMN Number
K972420
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LORENZ PECTUS SUPPORT BAR, 14IN PECTUS BAR HRS BIOMET MICROFIXATION, INC. NOT PROVIDED

Patients

Seq Age Sex Outcome Treatment
1 A STABLIZER MAY HAVE BEEN USED TO SECURE THE BAR