JOHNSON & JOHNSON GP7098 84-1070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-27 for JOHNSON & JOHNSON GP7098 84-1070 manufactured by Johnson & Johnson Orthopaedics Group.

Event Text Entries

[49542] Modified mcbride procedure on right foot, bunionectomy/osteotomy. Cellulitis developed post-op which did not respond to medical treatment. Return to or 3/13/96 for bone biopsy which showed osteomyelitis of the dorsum of the right foot and ankle. Surgeon believes implant was not sterile.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number78800
MDR Report Key78800
Date Received1997-01-27
Date of Report1996-04-29
Date of Event1996-01-26
Date Facility Aware1996-04-03
Report Date1996-04-29
Date Reported to Mfgr1996-04-29
Date Added to Maude1997-03-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameJOHNSON & JOHNSON
Generic NameORTHOSORB ABSORBABLE PIN
Product CodeMBJ
Date Received1997-01-27
Model NumberGP7098
Catalog Number84-1070
Lot Number*
ID Number*
Device Expiration Date2000-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key78420
ManufacturerJOHNSON & JOHNSON ORTHOPAEDICS GROUP
Manufacturer Address325 PARAMOUNT DR. RAYNHAM MA 027671086 US

Device Sequence Number: 2

Brand Name*
Date Received1997-01-27
Implant FlagN
Device Sequence No2
Device Event Key80259

Patients

Patient NumberTreatmentOutcomeDate
10 1997-01-27
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