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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS CORP. RESPONSE 5.5/6.0 SPINE SYSTEM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

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ORTHOPEDIATRICS CORP. RESPONSE 5.5/6.0 SPINE SYSTEM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Catalog Number 00-1003-4001
Device Problems Detachment Of Device Component (1104); Device Issue (2379)
Patient Problem Congenital Defect/Deformity (1782)
Event Date 03/02/2017
Event Type  Injury  
Event Description

Scheuermann's kyphosis case done (b)(6) 2016. Used all poly screws and 6. 0 cobalt chrome rods. Patient came back for 1 year follow up, and bottom 3 screws on both sides became disengaged. At time of revision surgery, sales rep noted that surgeon stated that he had used the wrong instrument (jimmy device) to actually reduce rod into pedicle screws, so therefore they were not tightened as he had thought.

 
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Brand NameRESPONSE 5.5/6.0 SPINE SYSTEM
Type of DevicePEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
Manufacturer (Section D)
ORTHOPEDIATRICS CORP.
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS CORP.
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
mark fox
2850 frontier drive
warsaw, IN 46582
5742686379
MDR Report Key6441955
MDR Text Key71099401
Report Number3006460162-2017-00005
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK15600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Notification
Type of Report Initial,Followup
Report Date 01/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00-1003-4001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2017
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
Removal/Correction NumberSEE H10

Patient TREATMENT DATA
Date Received: 03/29/2017 Patient Sequence Number: 1
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