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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR CUSTOMIZED-PLUS-L; IMPLANT
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STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR CUSTOMIZED-PLUS-L; IMPLANT Back to Search Results
Catalog Number 5444-1-310
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 08/08/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it was discarded by the facility at their location due to being a "biohazard".If additional information is received it will be reported in a supplemental report.The product was discarded by the facility at their location due to being a "biohazard".
 
Event or Problem Description
It was reported by a company representative that after an initial surgery was completed a revision surgery took place to remove the implant due to an infection.The infection was treated.No additional information is available regarding the infection.Medical intervention and adverse consequences of the revision surgery are unknown.
 
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Brand Name
MEDPOR CUSTOMIZED-PLUS-L
Common Device Name
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
MDR Report Key7834272
Report Number0008010177-2018-00078
Device Sequence Number11182255
Product Code FWP
UDI-Device Identifier07613327300420
UDI-Public07613327300420
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K153508
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/30/2018
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? Yes
Operator of Device Health Professional
Device Catalogue Number5444-1-310
Device Lot Number1803301006
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2018
Initial Report FDA Received Date08/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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