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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 UNKNOWN
Device Problem Device Issue (2379)
Patient Problem Congenital Defect/Deformity (1782)
Event Date 08/25/2016
Event Type  Injury  
Event Description

Spine rod / pedicle screw disassociated as the rod was not seated in the saddle. Towers were used and set screws appeared flush to the surgeon intraoperatively. Malfunction discovered during 9 month office follow up visit x-rays. Revision surgery completed. No patient information known. No other details after multiple attempts.

 
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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 Key5972740
MDR Text Key55442737
Report Number3006460162-2016-00006
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 08/25/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
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 Received08/25/2016
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: 09/23/2016 Patient Sequence Number: 1
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