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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM PEDICLE SCREW SPINAL SYSTEM

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ORTHOPEDIATRICS, CORP RESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to orthopediatrics for investigation as it is still 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 spinal deformity correction procedure, an x-ray taken at the one year follow-up revealed a possible fractured pedicle screw. The screw is located at the left pedicle at the t12 vertebrae. The patient presented with back pain following a collision in physical education class. Based on the computerized tomography scans and patient pain levels, a revision procedure could be performed at a later date. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameRESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM
Type of DevicePEDICLE SCREW SPINAL SYSTEM
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 Key7183941
MDR Text Key97053248
Report Number3006460162-2018-00002
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
Report Date 01/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00-1300-0640
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 Received12/14/2017
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: 01/11/2018 Patient Sequence Number: 1
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