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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS UNKNOWN ORTHOPEDIATRICS PEDINAIL IM FEMORAL NAIL PEDINAIL IM NAIL

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ORTHOPEDIATRICS UNKNOWN ORTHOPEDIATRICS PEDINAIL IM FEMORAL NAIL PEDINAIL IM NAIL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 11/21/2017
Event Type  Injury  
Manufacturer Narrative
Reference: (b)(4). Concomitant medical devices: unknown pedinail recon screw, item #: unknown, lot #: unknown. (b)(6). The device has not yet been returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2017-00032.
 
Event Description
It was reported that following the implantation of an intramedullary nail, follow-up x-rays discovered that the im nail and screw fractured at the proximal screw hole. The diagnosis was made three years post operatively. The patient has been scheduled for a revision procedure at an unknown date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN ORTHOPEDIATRICS PEDINAIL IM FEMORAL NAIL
Type of DevicePEDINAIL IM NAIL
Manufacturer (Section D)
ORTHOPEDIATRICS
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, IN 46582
5742670872
MDR Report Key7153461
MDR Text Key96003170
Report Number3006460162-2017-00031
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K083726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/28/2017
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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