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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC UNKNOWN ORTHOPEDIATRICS PEDICLE SCREW PEDICLE SCREW SPINAL SYSTEM

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ORTHOPEDIATRICS, INC UNKNOWN ORTHOPEDIATRICS PEDICLE SCREW PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Reporter has indicated that the product will not be returned to orthopediatrics for investigation as it remains implanted.

 
Event Description

It has been reported that following the placement of a spinal construct, a screw was noted to have fractured. No adverse events have been reported as a result of the malfunction.

 
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Brand NameUNKNOWN ORTHOPEDIATRICS PEDICLE SCREW
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, in 
2670872
MDR Report Key9744126
MDR Text Key190699023
Report Number3006460162-2019-00063
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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?
Event Location No Information
Date Manufacturer Received10/25/2019
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? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/24/2020 Patient Sequence Number: 1
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