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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
Model Number 00-1300-6645
Device Problem Device Issue (2379)
Patient Problem Congenital Defect/Deformity (1782)
Event Date 02/02/2017
Event Type  Injury  
Event Description

Idiopathic scoliosis surgery on (b)(6) year old female with 50 degree curve treated with response 5. 5/6. 0 system pedicle spinal system. Immediate post op x-rays show distal most screw on right side placed very near end of rod, with concerns expressed at time of surgery by company representative that this could become a problem. Subsequent follow up x-rays at 10 days post op showed the lower right side of the construct had dissociated. Surgeon elected to wait and see if fusion developed. About 13 months post op, patient noted a popping sound. Subsequent xray showed the lower left side of the construct had dissociated. This particular dissociation (distal left) looked like the head of the screw shank had come out of the tulip head. Devices involved were 6. 5 mm pedicle screws and 6. 0mm cocr diameter rod. Revision surgery performed on (b)(6) 2017: rod was extended on right side via use of stryker xia 2 system rod approximately 75 mm in length placed in parallel with existing rod to extend overall rod length. Both distal most screws replaced along with wedding band connector and (5) set screws total. Patient outcome successful but surgeon noted a slight compression on right side.

 
Manufacturer Narrative

Recall number: 3006460162-04-11-2017-001-c. A post operative x-ray was provided and the complaint was confirmed. A device history records review was unable to be performed as the lot number of the device involved in the event is unknown. Investigation results concluded that the reported event was due to the surgeon not adequately following the steps outlined in the surgical technique for "final tightening" of the set screw and the confirmation that the rod is fully seated into the bottom of the pedicle screw prior to tinal tightening. Updated surgical techinique, sales rep notifications and training has been updated and/or distributed. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Orthopediatrics will continue to monitor for trends.

 
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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 Key6364023
MDR Text Key68502452
Report Number3006460162-2017-00003
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
Remedial Action Notification
Type of Report Initial,Followup
Report Date 11/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number00-1300-6645
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/02/2017
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
Removal/Correction NumberSEE H10

Patient TREATMENT DATA
Date Received: 02/28/2017 Patient Sequence Number: 1
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