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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

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ORTHOPEDIATRICS CORP. RESPONSE 5.5/6.0 SPINE SYSTEM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 00-1003-6001
Device Problem Material Separation (1562)
Patient Problem Congenital Defect/Deformity (1782)
Event Type  Injury  
Manufacturer Narrative

Surgeon stated he was certain that the dissociation occurred due to the rod not being fully seated, and the driver not being able to overcome the force of the 6. 0mm cocr rod. Surgeon further stated that when he performed the revision surgery on the patient, he observed that the rod was not fully seated. Upon utilizing the reduction tower to fully seat the rod into the pedicle screw, he observed that the rod did reduce further. He then final tightened the set screw using the torque limiting driver handle.

 
Event Description

Set screw disassociated from polyaxial screw causing rod to disengage from polyaxial screw. Surgeon discovered at 6-week follow-up visit with patient.

 
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Brand NameRESPONSE 5.5/6.0 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 Key5930748
MDR Text Key53995751
Report Number3006460162-2016-00002
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150600
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 Received09/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00-1003-6001
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 Received03/04/2016
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: 09/06/2016 Patient Sequence Number: 1
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