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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, PRODUCT CODE:OSH

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ORTHOPEDIATRICS CORP. RESPONSE 5.5/6.0 SPINE SYSTEM PEDICLE SCREW SPINAL SYSTEM, PRODUCT CODE:OSH Back to Search Results
Catalog Number 00-1003-4001
Device Problem Detachment Of Device Component (1104)
Patient Problem Congenital Defect/Deformity (1782)
Event Date 08/02/2016
Event Type  Injury  
Manufacturer Narrative

Set screw disassociated from polyaxial screw causing rod to disengage from polyaxial screw. Surgeon discovered at 6-week follow-up visit with patient. 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 intended to assure the rod is fully seated into the pedicle screw, he observed that the rod did reduce further. He then final tightened the set screw using the toque limiting driver handle. Reduction tower instruments are provided to specifically provide additional mechanical advantage to aid surgeon in seating the rod into the bottom of the pedicle screw prior to final tightening of set screw. Surgical technique shows how to visually or via palpitation confirm that set screw is fully seated. Device not returned for evaluation.

 
Event Description

During a post-op follow-up visit, it was noted on x-ray that one of the 6. 0 cocr rods had dissociated from the pedicle screw. A revision surgery was performed that same day.

 
Manufacturer Narrative

(b)(4). Recall number: 3006460162-04-11-2017-001-c.

 
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Brand NameRESPONSE 5.5/6.0 SPINE SYSTEM
Type of DevicePEDICLE SCREW SPINAL SYSTEM, PRODUCT CODE:OSH
Manufacturer (Section D)
ORTHOPEDIATRICS CORP.
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
mark fox
2850 frontier drive
warsaw, IN 46582
5742686379
MDR Report Key5934477
MDR Text Key54140287
Report Number3006460162-2016-00003
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
Remedial Action Notification
Type of Report Initial,Followup
Report Date 11/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2016
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/02/2016
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
Removal/Correction NumberSEE H10

Patient TREATMENT DATA
Date Received: 09/07/2016 Patient Sequence Number: 1
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