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U.S. Department of Health and Human Services

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

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ORTHOPEDIATRICS CORP. RESPONSE 5.5 SPINE SYSTEM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Catalog Number 00-1003-4001
Device Problem Detachment Of Device Component (1104)
Patient Problem Congenital Defect/Deformity (1782)
Event Date 07/08/2016
Event Type  Malfunction  
Manufacturer Narrative

Revision surgery performed (b)(6) 2016 to reattach rod/pedicle screws. Outcome positive.

 
Event Description

Distal two set screws on left spine rod and single most distal set screw on right of spine rod of construct disassociated from pedicle screw. Discovered on routine post surgical follow up visit x-rays.

 
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Brand NameRESPONSE 5.5 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 Key5957118
MDR Text Key54993163
Report Number3006460162-2016-00005
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 08/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00-1003-4001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2016
Was Device Evaluated By Manufacturer? No
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: 09/16/2016 Patient Sequence Number: 1
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