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U.S. Department of Health and Human Services

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

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MEDCAD ACCUSHAPE PEEK PATIENT-SPECIFIC CRANIAL IMPLANT Back to Search Results
Catalog Number ACSL-003
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); No Information (3190)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
An investigation into the event is ongoing. A follow-up report will be filed upon completion of the investigation.
 
Event Description
Through internal review of historical cases, medcad discovered that approximately 6 months after providing an accushape patient-specific cranial implant (psci) for the patient, a second implant was provided for the same patient with the same defect, indicating that the previous accushape psci was explanted.
 
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Brand NameACCUSHAPE
Type of DevicePEEK PATIENT-SPECIFIC CRANIAL IMPLANT
Manufacturer (Section D)
MEDCAD
501 s. 2nd ave.
suite a1000
dallas TX 75226
Manufacturer (Section G)
MEDCAD
501 s. 2nd ave.
suite a1000
dallas TX 75226
Manufacturer Contact
estelle anuwe
501 s. 2nd ave.
suite a1000
dallas, TX 75226
2144538864
MDR Report Key9548805
MDR Text Key174868416
Report Number3009196021-2020-00001
Device Sequence Number1
Product Code GXN
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberACSL-003
Device Lot Number171702 ANR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2017
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: 01/03/2020 Patient Sequence Number: 1
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