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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOPRO, INC. BIOPRO GREAT TOE MP JOINT; TOE JOINT
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BIOPRO, INC. BIOPRO GREAT TOE MP JOINT; TOE JOINT Back to Search Results
Model Number 10060
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/02/2014
Event Type  Injury  
Event Description
Component was implanted after sterile expiration date.Expiration date was on 04/2014 and product was implanted on (b)(6) 2014.
 
Manufacturer Narrative
Facility implanted the component after the sterile expiration date.They were not aware of this.Customer service at manufacturer noticed this when the order was faxed in and date was on patient sticker.Current sterilization validation window gives a leeway of 5 months after expiration date.Therefore, manufacturer is confident that component was still sterile.
 
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Brand Name
BIOPRO GREAT TOE MP JOINT
Type of Device
TOE JOINT
Manufacturer (Section D)
BIOPRO, INC.
port huron MI
Manufacturer Contact
patrick pringle
2929 lapeer rd.
port huron, MI 48060
8109827777
MDR Report Key3839180
MDR Text Key4410880
Report Number1833506-2014-00001
Device Sequence Number1
Product Code KWD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2014
Device Model Number10060
Device Lot Number107471
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2009
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) Other;
Patient Age70 YR
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