DEPUY ACE OPEN BACK HALO RING-LARGE 1305

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 1997-06-12 for DEPUY ACE OPEN BACK HALO RING-LARGE 1305 manufactured by Depuy Ace Medical Co..

Event Text Entries

[20524582] When mri of cervical spine was attempted, patient described severe pain in 2 posterior pin sites of halo ring.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020311-1997-00021
MDR Report Key98733
Report Source07
Date Received1997-06-12
Date of Report1997-06-06
Date of Event1997-04-08
Date Facility Aware1997-04-18
Report Date1997-06-06
Date Mfgr Received1997-04-18
Date Added to Maude1997-06-19
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 Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEPUY ACE OPEN BACK HALO RING-LARGE
Generic NameHALO RING
Product CodeKQZ
Date Received1997-06-12
Model NumberNA
Catalog Number1305
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key97310
ManufacturerDEPUY ACE MEDICAL CO.
Manufacturer Address2260 EAST EL SEGUNDO BLVD. EL SEGUNDO CA 90245 US
Baseline Brand NameOPEN BACK HALO RING-LARGE
Baseline Generic NameHALO RING
Baseline Model NoNA
Baseline Catalog No1305
Baseline ID*
Baseline Device FamilyCERVICAL
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK914858
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1997-06-12

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