ZEPF 52-400-00B/52-482-03 EB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-09 for ZEPF 52-400-00B/52-482-03 EB manufactured by Gebruder Zepf.

Event Text Entries

[5628619] Kerrison#3 was used during a spinal case. The kerrison was attached to dura tissue and would not release. The dura tissue had to be cut away from the kerrison.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5041425
MDR Report Key4604324
Date Received2015-03-09
Date of Report2015-03-09
Date of Event2015-03-03
Date Added to Maude2015-03-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameZEPF
Generic NameKERRISON #3
Product CodeHAD
Date Received2015-03-09
Model Number52-400-00B/52-482-03 EB
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerGEBRUDER ZEPF
Manufacturer AddressDURBHEIM, DE 78589 78589


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-03-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.