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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 ACS_XL_D
Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)
Event Date 09/05/2017
Event Type  Injury  
Manufacturer Narrative
Review of the device's production records revealed that no nonconformities were generated during the production of this device that would contribute to the condition described in this event. 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 a request for the patient's weight, were attempted on 11/09/2017, 11/20/2017, and 02/20/2018. Medcad has not received further information from the initial reporter.
 
Manufacturer Narrative
Device was used for treatment and not for diagnosis. Evaluation of the device could not be completed as no device was returned to medcad. Device is not expected to be returned. It was reported by a company representative that prior to the implantation surgery, on the date of surgery, the patient displayed an open sore over a previous titanium mesh implant. The site was treated with an antiseptic and the device was implanted. A review of the device history record (dhr) was performed for the specific lot number. A review of the device's labeling and production records was performed as well. Evaluation is still in progress. A follow-up report will be submitted as appropriate once investigation is complete or if information is obtained that was not available for the initial report.
 
Event Description
On (b)(6) 2017, medcad received notification from a distributor that an accushape peek patient-specific implant, as well as supporting unknown plates and screws, were removed from a patient. The distributor reported that the device was implanted on (b)(6) 2017 and that the device was removed from the patient on (b)(6) 2017, after the patient returned with an open wound over the implant site. It was reported by a company representative that prior to the implantation surgery, on the date of surgery, the patient displayed an open sore over a previous titanium mesh implant. The site was treated with an antiseptic and the device was implanted.
 
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Brand NameACCUSHAPE
Type of DevicePEEK PATIENT-SPECIFIC IMPLANT
Manufacturer (Section D)
MEDCAD
501 s. 2nd ave.
suite 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 Key7068007
MDR Text Key113407389
Report Number3009196021-2017-00008
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 company representative,distri
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 Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberACS_XL_D
Device Lot Number171742 SAN
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 Received10/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2017
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: 11/29/2017 Patient Sequence Number: 1
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