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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCAD OSTEOMATCH; PEEK PATIENT-SPECIFIC IMPLANT 100-150 SQ CM
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MEDCAD OSTEOMATCH; PEEK PATIENT-SPECIFIC IMPLANT 100-150 SQ CM Back to Search Results
Catalog Number ACSM-002
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis.Date of initial implant is (b)(6) 2016.Exact date is unknown.Date of explant is 2017.Exact date is unknown.Analysis of the device could not be completed as no product was returned to the manufacturer.The subject device is not expected to be returned to the manufacturer.If information is obtained after time of initial submission, it will be filed as appropriate.Device not returned to manufacturer.
 
Event Description
It was reported that a peek patient-specific implant (psi) was removed from a male patient after discovery of an infection.The report stated that the implant had been removed 2-3 months prior to the date that medcad was notified, and that the patient's infection had since been cleared.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Date of initial implant is (b)(6) 2016.Exact date is unknown.Date of explant is 2017.Exact date is unknown.Analysis of the device could not be completed as no product was returned to the manufacturer.The subject device is not expected to be returned to the manufacturer.If information is obtained after time of initial submission, it will be filed as appropriate.Initial report of the event was received by the manufacturer on 04/17/2017, not on 05/15/2017 as previously reported.A review of the product's device history record was completed on 06/05/2017, including a review of the product's labeling and manufacturing processes.No issues were found during review of the product's dhr, or manufacturing or labeling, that would contribute to the condition described by the reporter.Analysis of the actual device could not be completed, as no device was received.The subject device is not expected to be returned to the manufacturer for evaluation.Non non-conformances were generated during the production of the subject device.Additional correspondence with the reporter identified that the patient had previous infection that was not completely removed prior to implanting the peek device.Reporter stated that the psi was removed to clear the remaining infection.Reporter stated that the infection has since been cleared and that the patient was in stable condition prior to follow-up surgery.
 
Event Description
It was reported that a peek patient-specific implant (psi) was removed from a male patient after discovery of an infection.The report stated that the implant had been removed 2-3 months prior to the date that medcad was notified, and that the patient's infection had since been cleared.
 
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Brand Name
OSTEOMATCH
Type of Device
PEEK PATIENT-SPECIFIC IMPLANT 100-150 SQ CM
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 Key7077384
MDR Text Key93558726
Report Number3009196021-2017-00003
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 Physician
Type of Report Initial,Followup
Report Date 04/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue NumberACSM-002
Device Lot Number161560 NEL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age57 YR
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