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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCAD ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT

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MEDCAD ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT Back to Search Results
Catalog Number MC-SPK40
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
The specific date of implantation us unknown. The date of explant is unknown, though the distributor sales representative reported on november 27, 2018, that the device was explanted the day after implantation. Evaluation for this event is still in progress. A follow-up report will be filed as appropriate once evaluation is complete or if additional information is obtained that was not available for the initial report.
 
Event Description
On november 27, 2018, medcad was notified by distributor sales representative that the accushape patient-specific cranial implant was explanted from the patient the day after implantation. The complainant reported that the patient experienced an increase in intracranial pressure.
 
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Brand NameACCUSHAPE
Type of DevicePEEK PATIENT-SPECIFIC IMPLANT
Manufacturer (Section D)
MEDCAD
501 s. 2nd ave.
suite a1000
dallas,
Manufacturer (Section G)
MEDCAD
501 s. 2nd ave.
suite a1000
dallas,
Manufacturer Contact
estelle anuwe
501 s. 2nd ave.
suite a1000
dallas, 
MDR Report Key8161722
MDR Text Key130311532
Report Number3009196021-2018-00003
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
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 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMC-SPK40
Device Lot Number183079 TSA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2018
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: 12/13/2018 Patient Sequence Number: 1
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