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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
Model Number N/A
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment and not diagnosis. Evaluation of the device could not be completed, as no devices were returned. Device is not expected to be returned for evaluation. Exact date of implant and exact date of explant are unknown. According to the complainant, the patient and family of the patient have a history of reaction to implants. No testing was completed to confirm source of reaction. A device history record (dhr) review was performed for the specific lot number. Review of the dhr, device labeling, and production records showed that there were no issues during the manufacture of the device that would contribute to the condition described in this complaint. If information is obtained that was not available for the initial report, a follow-up report will be filed, as appropriate.
 
Event Description
Medcad received notification that patient experienced a reaction to the implant and that the implant was removed.
 
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Brand NameACCUSHAPE
Type of DevicePEEK PATIENT-SPECIFIC IMPLANT
Manufacturer (Section D)
MEDCAD
501 s. 2nd ave.
ste. a-1000
dallas TX 75226
Manufacturer (Section G)
MEDCAD
501 s. 2nd ave.
ste. a-1000
dallas TX 75226
Manufacturer Contact
estelle anuwe
501 s. 2nd ave.
ste. a-1000
dallas, TX 75226
2144538864
MDR Report Key6979887
MDR Text Key90330212
Report Number3009196021-2017-00005
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 distributor
Reporter Occupation
Type of Report Initial
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberACSS-001
Device Lot Number161539 REY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2016
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: 10/26/2017 Patient Sequence Number: 1
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