EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5 199721000

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 2020-03-13 for EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5 199721000 manufactured by Medos International Sàrl Ch.

Event Text Entries

[184153736] If the information is unknown, not available or does not apply, the section/field of the form is left blank. Initial reporter is synthes sales representative. Without a lot number the device history records review could not be completed. Product was not returned. Device was used for treatment, not diagnosis. 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


[184153737] Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, several expedium verse dual innies broke intraoperatively in a complex skoliosis case. The surgeon claims that inpropper handling can be excluded. Outer ring of dual innie broke while final "tighetening". Broken dual innies also destroyed the thread of the implanted screws. The polyaxial mechanisms of another screw head blocked and needed to be replaced. There was a surgical delay of thirty (30) minutes. Concomitant devices reported: expedium verse spine system verse correction key 5. 5 (part#: 199721000, lot#: unknown, quantity#: 8), 5. 5 exp verse fen scr 5. 0x45 (part#: unknown, lot#: unknown, quantity#: 9), unknown mono/polyaxial screws (part#: unknown, lot#: unknown, quantity#: 1). This report is for one (1) expedium verse spine system verse correction key 5. 5. This is report 3 of 8 for (b)(4). This (b)(4) capture the 9 out of 19 devices reported and (b)(4) capture the 10 out of 19 devices reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2020-00707
MDR Report Key9829886
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-13
Date of Report2020-02-17
Date of Event2020-02-05
Date Mfgr Received2020-02-17
Date Added to Maude2020-03-13
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 ContactKARA DITTY-BOVARD
Manufacturer StreetCHEMIN-BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal02400
Manufacturer Phone6103142063
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 NameEXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5
Generic NameAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Product CodeKWQ
Date Received2020-03-13
Model Number199721000
Catalog Number199721000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-13

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