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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 00-1300-4001
Device Problem Device Issue (2379)
Patient Problem Congenital Defect/Deformity (1782)
Event Type  Injury  
Event Description

Surgeon advised that he had a patient come in for routine follow up and presented with pain. X-ray indicated that both of the lateral connectors have disengaged from the iliac screws at some point between the office visit and the surgery ((b)(6) 2016). Revision surgery performed on (b)(6) 2017: lateral connectors dissociated from the 2 screws at the bottom of the construct. One side was 5. 5 cocr, the other side was a 6. 0 cocr rod the initial surgery predated surgeon retraining and his use of towers at the bottom of the construct. Removed 2 screws that were spanning the si joint. Removed all set screws and rods from the construct. Left the pedicle screws in place. Added 2 7 x 25 poly screws in s1 and 28 x 80 poly screws in s2 replaced the original rods with 5. 5 titanium rods. Utilized towers at bottom of the construct and most other pedicle screws. Jiminys used to help reduce the rod and towers for final reduction. Used 95inlb torque drivers to set the screws. Utilized a fixed t-handle to provide additional torque to the set screws.

 
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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 Key6406440
MDR Text Key70013992
Report Number3006460162-2017-00314
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
PMA/PMN NumberK150600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 03/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number00-1300-4001
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Device Age6 mo
Event Location No Information
Date Manufacturer Received02/14/2017
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 Initial

Patient TREATMENT DATA
Date Received: 03/15/2017 Patient Sequence Number: 1
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