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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 ACSM-002
Device Problems Patient-Device Incompatibility (2682); Device Handling Problem (3265)
Patient Problem Unspecified Infection (1930)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Review of the device's production records revealed that the device was manufactured in compliance with medcad's manufacturing procedures. Medcad was notified on 03/23/2017 by the complainant via phone call that the device had been handled in a way that was not in accordance with the specification provided in the instructions for use. Specifically, fixation materials were added to the implant prior to sterilization. Review of the device's labeling revealed that instructions for use were provided that included contraindications, warnings and sterilization instructions to be used to ensure that the implant is sterile. Requests for additional information, including patient's weight, were attempted on 10/19/2017 via email and 10/24/2017 via phone. Medcad has not received further information from the complainant.
 
Manufacturer Narrative
Device was used for treatment and not for diagnosis. Evaluation of the device could not be completed as the device was discarded after explant. The exact date of implant and exact date of explant are unknown. A review of the device history record (dhr) for this specific lot number was performed. A review of the labeling and production records for this lot number was also performed. 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 march 3, 2017, medcad received notification from a sales representative that an accushape peek patient-specific implant was removed from a patient. It was reported by the sales representative that the device was implanted in (b)(6) 2016, and that the device was removed in 2017 after the patient experienced an infection. Exact date of implant and exact date of explant are unknown.
 
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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.
suite a-1000
dallas TX 75226
Manufacturer Contact
estelle anuwe
501 s. 2nd ave.
suite a-1000
dallas, TX 75226
2144538864
MDR Report Key7065427
MDR Text Key254933165
Report Number3009196021-2017-00007
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,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberACSM-002
Device Lot Number161517 MAX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2016
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: 11/28/2017 Patient Sequence Number: 1
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