ACTIV L SUP.PLATE SIZE L 11?/SPIKES SW992K

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 2020-03-04 for ACTIV L SUP.PLATE SIZE L 11?/SPIKES SW992K manufactured by Aesculap Ag.

Event Text Entries

[182305781] 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


[182305782] It was reported that there was an issue with activ l sup. Plate. According to the customer description: "a (b)(6) year old male weighing (b)(6) kg had a removal of activl artificial disc and replaced with 360 fusion". The original implantation had been performed on (b)(6) 2019. A revision surgery was necessary. Additional information has been requested. The adverse event is filed under (b)(4). Associated medwatch-reports: 9610612-2020-00060 ((b)(4) sw966). 9610612-2020-00061 ((b)(4) sw996k).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2020-00059
MDR Report Key9786839
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-04
Date of Report2020-03-04
Date of Event2020-02-14
Date Mfgr Received2020-02-12
Date Added to Maude2020-03-04
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 SUP.PLATE SIZE L 11?/SPIKES
Generic NameSPINE SURGERY
Product CodeMJO
Date Received2020-03-04
Model NumberSW992K
Catalog NumberSW992K
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
101. Required No Informationntervention 2020-03-04

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