5.5 EXP VERSE FEN SCR 7.0X60 199723760

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-10-23 for 5.5 EXP VERSE FEN SCR 7.0X60 199723760 manufactured by Medos International Sàrl Ch.

Event Text Entries

[125612695] Product complaint # ==> (b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[125612696] It was reported that the top notch on one of the implanted verse advance screws broke off, all the innies and the rod had to be removed and the screw replaced with a new screw since the broken screw would not allow a innie to lock. Patient consequence? : no. Action taken for procedure: or time was prolonged by 1 hour, because everything had to be removed to replace the broken screw. Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2018-51007
MDR Report Key7997052
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-10-23
Date of Report2018-10-09
Date of Event2018-10-09
Date Mfgr Received2018-11-08
Date Added to Maude2018-10-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJASON BUSCH
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone5088808100
Manufacturer G1MEDOS INT SPINE
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5.5 EXP VERSE FEN SCR 7.0X60
Generic NameBONE CEMENT, POSTERIOR SCREW AUGMENTATION
Product CodePML
Date Received2018-10-23
Model Number199723760
Catalog Number199723760
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-23

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