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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

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ORTHOPEDIATRICS CORP. RESPONSE 5.5 SPINE SYSTEM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 00-1003-4001
Device Problem Material Separation (1562)
Patient Problem Congenital Defect/Deformity (1782)
Event Type  Injury  
Manufacturer Narrative

Surgeon informed manufacturer that the set screw on the left side (most distal) was probably cross threaded. The 6-month follow up x-rays show that the rod had slipped in the axially direction and the surgeon confirmed this in the revision surgery. Additionally, the next level up on the left side from the most distal screw also showed slip along the rod. The surgeon also noted slippage on the same two most distal screws on the right side. The surgeon stated he was unsure if he used the correct torque limiter upon final tightening. Device not returned for evaluation.

 
Event Description

Both cocr rods found to be disassociated from the distal pedicle screws in construct, via x-ray at 6-month follow up.

 
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Brand NameRESPONSE 5.5 SPINE SYSTEM
Type of DevicePEDICLE SCREW SPINAL SYSTEM
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 Key5930751
MDR Text Key53995793
Report Number3006460162-2016-00001
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 06/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2016
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? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2016
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: 09/06/2016 Patient Sequence Number: 1
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