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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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Photographs of the x-rays were provided for review and confirm that the screw backed out of the nail. Device history records review could not be completed as the item and lot numbers were unknown. A complaint history review could not be completed as the item and lot numbers were unknown. Based on the information provided regarding the patients' medical history and that she had been admitted to the er due to a fall, it was determined the root cause is most likely due to human factors. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Orthopediatrics will continue to monitor for trends.
 
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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
MDR Report Key7367478
MDR Text Key103405584
Report Number3006460162-2018-00017
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K083726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/23/2018 Patient Sequence Number: 1
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