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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 Detachment Of Device Component (1104)
Patient Problem Congenital Defect/Deformity (1782)
Event Date 11/11/2016
Event Type  Injury  
Event Description

Spine rod / pedicle screw disassociated. It is unknown if tower instruments were utilitized during initial surgery. Malfunction discovered 4 months post op. Revision surgery completed with positive outcome. No patient information known.

 
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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
warsw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS CORP.
2850 frontier drive
warsw IN 46582
Manufacturer Contact
mark fox
2850 frontier drive
warsaw, IN 46580
5742686379
MDR Report Key6138238
MDR Text Key61232598
Report Number3006460162-2016-01130
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 BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 11/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
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

Patient TREATMENT DATA
Date Received: 12/01/2016 Patient Sequence Number: 1
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