PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FI UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-11-12 for PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FI UNK manufactured by Interpore Intl..

Event Text Entries

[16621227] March 16, 1995, the patient developed a wound dehiscence and was admitted to the hospital march 18, 1995 for formal inpatient whirlpool treatment and surgical debridement with iv antibiotics. Culture taken grew a heavy growth of staphylococcus aureus at the time of discharge. 03/23/95. On 05/2/95, a small subcutaneous pinpoint abscess was noted at the inferior pole of the patella. The physician recommended additional surgery for hardware removal and probable resection of the proximal pole of the patella, however, the patient refused. The patient was treated with outpatient whirlpool and placed on keflex. The patient was subsequently admitted to the hospital for hardware removal and i&d on 05/19/95. A fibrous union was deteched with no evidence of infection in deep layers or bone. As of 06/8/95, the cast was removed and the wound was healed. No evidence of recurrence of infection was noted. On 08/17/97, the patient was intoxicated, slipped and fell resulting in increased separation at the fracture site. The patient was instructed to use an immobilizer for six weeks. The patient subsequently "lost" the immobilizer and further displacement was noted on x-ray. On 8/20/97, a partial patellectomy was performed. On 9/14/97, the patient was doing well and the wound was healed without evidence of infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029012-1997-00098
MDR Report Key132644
Report Source00
Date Received1997-11-12
Date of Report1997-11-12
Date of Event1995-03-16
Date Mfgr Received1997-10-16
Date Added to Maude1997-11-18
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
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FI
Generic NameENDOSSEOUS IMPLANT
Product CodeMBS
Date Received1997-11-12
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date RemovedA
Device Sequence No1
Device Event Key129647
ManufacturerINTERPORE INTL.
Manufacturer Address181 TECHNOLOGY DR. IRVINE CA 926182402 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1997-11-12

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