SYNERGY SPINAL SYSTEM 6007

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 2003-06-20 for SYNERGY SPINAL SYSTEM 6007 manufactured by Interpore Cross Intl..

Event Text Entries

[18601826] Pt orginally had surgery in 2003. The pt was experiencing pain post-operatively. Post-op x-rays were performed and revealed that the left rod had slipped 2" cephally. Pt had a second surgery in 2003. During the revision, both sides were found to be loose. New vls caps and a rod were put in.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029012-2003-00021
MDR Report Key467686
Report Source07
Date Received2003-06-20
Date of Report2003-06-20
Date of Event2003-05-24
Device Manufacturer Date2002-05-01
Date Added to Maude2003-06-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactCAROL BERARD
Manufacturer Street181 TECHNOLOGY DR
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 Received2003-06-20
Model NumberNA
Catalog Number6007
Lot Number31554
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key456611
ManufacturerINTERPORE CROSS INTL.
Manufacturer Address181 TECHNOLOGY DR. IRVINE CA 92618 US
Baseline Brand NameTI SYNERGY RODS
Baseline Generic NameORTHOPEDIC IMPLANT
Baseline Model NoNA
Baseline Catalog No6007
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. Hospitalization 2003-06-20

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