SYNERGY SPINAL SYSTEM 6009

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-08-13 for SYNERGY SPINAL SYSTEM 6009 manufactured by Interpore Cross Intl..

Event Text Entries

[338017] Pt underwent re-operation because cap nuts on the construct were reported to be loose.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029012-2004-00030
MDR Report Key539120
Report Source07
Date Received2004-08-13
Date of Report2004-08-12
Date of Event2004-06-10
Date Mfgr Received2004-08-02
Device Manufacturer Date2002-06-01
Date Added to Maude2004-08-17
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 Location0
Manufacturer ContactMARY CARVAJAL
Manufacturer Street181 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9494533200
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNERGY SPINAL SYSTEM
Generic NameORTHOPEDIC IMPLANT
Product CodeKWO
Date Received2004-08-13
Returned To Mfg2004-08-02
Model NumberNA
Catalog Number6009
Lot Number31554
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key528415
ManufacturerINTERPORE CROSS INTL.
Manufacturer Address* IRVINE CA * US
Baseline Brand NameTI SYNERGY RODS
Baseline Generic NameORTHOPEDIC IMPLANT
Baseline Model NoNA
Baseline Catalog No6009
Baseline IDNA
Baseline Device FamilySYNERGY SPINAL SYSTEM
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK950709
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2004-08-13

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