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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP UNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW

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ORTHOPEDIATRICS, CORP UNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Fall (1848)
Event Date 02/23/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to orthopediatrics for investigation as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It has been reported that following a fall, the patient was admitted into the emergency room where it was discovered that the proximal locking screw of the implanted pedinail system had backed out. The patient was scheduled same day for a tibial fracture reduction and screw advancement. No additional patient consequences were reported.
 
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Brand NameUNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW
Type of DeviceUNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
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 Key7367478
MDR Text Key103405584
Report Number3006460162-2018-00017
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received04/02/2018
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: 03/23/2018 Patient Sequence Number: 1
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