ACTIV L REVISION DISTRACT.FORCEPS ANGLED FW965R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for ACTIV L REVISION DISTRACT.FORCEPS ANGLED FW965R manufactured by Aesculap Ag.

Event Text Entries

[182934881] Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[182934882] It was reported that there was an issue with an activ l forcep. The tip of the instrument was broken during distraction of an endplate. The procedure was a lumber total disc replacement. This incident did cause a 5 minute delay in surgery. There was no patient harm. Additional intervention was not required. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2020-00068
MDR Report Key9813518
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-14
Date Mfgr Received2020-02-14
Date Added to Maude2020-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal78501
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACTIV L REVISION DISTRACT.FORCEPS ANGLED
Generic NameSPINE SURGERY
Product CodeMJO
Date Received2020-03-10
Model NumberFW965R
Catalog NumberFW965R
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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