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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCAD ACCUSHAPE CRANIPLASTY PLATE

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MEDCAD ACCUSHAPE CRANIPLASTY PLATE Back to Search Results
Model Number MC-SPK30
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
It was reported by distributor sales representative that the patient had an infection at the implant site and that the accushape patient-specific cranial implant was planned to be explanted. Investigation into the reported adverse event is underway. A follow-up report will be filed pending completion of the investigation.
 
Event Description
It was reported that the patient presented with an infection at the implant site and that the cranial implant was planned to be explanted.
 
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Brand NameACCUSHAPE
Type of DeviceCRANIPLASTY PLATE
Manufacturer (Section D)
MEDCAD
501 south second ave
suite a1000
dallas, tx
Manufacturer (Section G)
MEDCAD
501 south second ave
suite a1000
dallas, tx
Manufacturer Contact
james allo
501 south second ave
suite a1000
dallas, tx 
4538864
MDR Report Key9904291
MDR Text Key191106568
Report Number3009196021-2020-00005
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810007630113
UDI-Public(01)00810007630113(10)193764BAK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMC-SPK30
Device Catalogue NumberMC-SPK30
Device Lot Number193764BAK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/31/2020 Patient Sequence Number: 1
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