IMPL SYS,BIO-COMP ACHILLES SPEEDBRG AR-8928BC-CP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for IMPL SYS,BIO-COMP ACHILLES SPEEDBRG AR-8928BC-CP manufactured by Arthrex, Inc..

Event Text Entries

[186328359] The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10


[186328360] It was reported by the patient that she had undergone a haglunds and achilles procedure on her foot on (b)(6) 2018. Her medical records note that the surgeon had implanted an arthrex speedbridge implant, ar-8928bc-cp. Patient has a known allergy to latex and surgeon also noted in her records that her implant needed to be a metal composition. Patient also disclosed that sometime in her past she has experienced issues when wearing costume jewelry and so has since avoided such jewelry. Since the surgery the patient has developed numerous issues in her foot. The foot is swollen with what appears to be a large growth. She has a stinging/ pins and needles feeling in the top of foot and has developed what looks similar to a psoriasis type outbreak on the bottom of her foot. She continually has leg cramps at night and when stepping out of bed has a tremendous amount of pain in her foot. She has undergone a year of intense therapy to help with the hypersensitivity issues she is also experiencing but although some relief the issues have continually gotten worse since the surgery. The patient has requested the material composition of the implant components which will be provided to her. The patient medical records also noted an amino tissue from active sky matrix on the tissue log indicating that she may have received some sort of tissue bank product during the surgery as well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220246-2020-01767
MDR Report Key9883039
Report SourceCONSUMER
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-26
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 Location3
Manufacturer ContactVIK BAJNATH
Manufacturer Phone8009337001
Manufacturer G1ARTHREX, INC.
Manufacturer Street1370 CREEKSIDE BOULEVARD
Manufacturer CityNAPLES FL 341081945
Manufacturer CountryUS
Manufacturer Postal Code341081945
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPL SYS,BIO-COMP ACHILLES SPEEDBRG
Generic NameFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Product CodeMAI
Date Received2020-03-26
Model NumberIMPL SYS,BIO-COMP ACHILLES SPEEDBRG
Catalog NumberAR-8928BC-CP
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

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