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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 00-1300-6051
Device Problem Malposition of Device (2616)
Patient Problem Congenital Defect/Deformity (1782)
Event Date 08/17/2016
Event Type  Injury  
Event Description

Use error by surgeon. Spine rod cut too short for final construct. Most distal screw did not have adequate purchase on spine rod as seen in x-ray. Discovered rod/screw disassociation on follow up visit.

 
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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 Key5945569
MDR Text Key54526614
Report Number3006460162-2016-00004
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130655
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 08/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00-1300-6051
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2016
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: 09/13/2016 Patient Sequence Number: 1
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