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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
Model Number MC-SPK40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
An investigation into the reported event is ongoing.A follow-up report will be filed upon completion of the investigation.
 
Event Description
It was reported that the cranial implant was explanted after the patient presented with an infection.
 
Manufacturer Narrative
On november 16, 2020 medcad was notified by telephone that the accushape peek patient-specific cranial implant was explanted after the patient presented with an infection.The device was used for treatment and not for diagnosis.On november 18, 2020 the initial reporter was contacted via email for additional information about the reported adverse event.The information requested included additional clarification as to the nature of the reported infection, including whether the source of the infection had been identified.Also requested were the date the device in question was explanted and the weight of the patient at the time of the event.A follow up was made again on november 24, 2020 in an attempt to collect this information.Distribution records indicated that a replacement patient-specific cranial implant was provided for the patient by medcad on (b)(6) 2020.On december 9, 2020 contact with the initial reporter was made by telephone.According to the initial reporter, "everything went well" with the revision surgery using the replacement peek cranial implant.The initial reporter also stated that he would attempt to obtain the requested information from surgeon dr.(b)(6).On january 4, 2021 the initial reporter informed medcad by telephone that he was unable to obtain the requested information from dr.(b)(6).Communication with the initial reporter was unable to determine the nature of the reported infection.The date of explant and the weight of the patient at the time of the event could not be determined.Investigation into the device history record was performed.According to production records, the device was produced in conformance with all production requirements.No nonconformance was identified during production.Investigation did not identify any device problems.The cause of the reported infection could not be established.
 
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Brand Name
ACCUSHAPE
Type of Device
PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
Manufacturer (Section D)
MEDCAD
501 south second ave
suite a1000
dallas TX 75226
MDR Report Key10980069
MDR Text Key220642751
Report Number3009196021-2020-00014
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810007630120
UDI-Public(01)00810007630120(10)204847MUR
Combination Product (y/n)N
PMA/PMN Number
K110684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMC-SPK40
Device Catalogue NumberMC-SPK40
Device Lot Number204847MUR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/16/2020
Initial Date FDA Received12/09/2020
Supplement Dates Manufacturer Received11/16/2020
Supplement Dates FDA Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
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