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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. STEM+(2)PINS. (RX)DR.MONSON

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MICROPORT ORTHOPEDICS INC. STEM+(2)PINS. (RX)DR.MONSON Back to Search Results
Model Number CPEF0072
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Allegedly, patient underwent a revision surgery due to the repiphysis stem fracturing at the taper that connected to the custom adapter. The repiphysis stem and custom adapter were removed and a longer midsection and segmental stem were placed.
 
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Brand NameSTEM+(2)PINS. (RX)DR.MONSON
Type of DeviceSTEM
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key9859486
MDR Text Key184251743
Report Number3010536692-2019-01124
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCPEF0072
Device Catalogue NumberCPEF0072
Device Lot Number1123214
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/30/2019
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/20/2020 Patient Sequence Number: 1
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