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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAMBER SPINE TECHNOLOGIES ORTHROS Ø7.5MM POLYAXIAL REDUCTION PEDICLE SCREW , 40MM LG.

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CAMBER SPINE TECHNOLOGIES ORTHROS Ø7.5MM POLYAXIAL REDUCTION PEDICLE SCREW , 40MM LG. Back to Search Results
Model Number ORO-7540R
Device Problem Fracture (1260)
Patient Problem Arthritis (1723)
Event Date 10/31/2017
Event Type  Malfunction  
Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint october 31, 2017. The subject product has not been returned to the manufacturer for evaluation. Independent review of medical records indicates contributing factors include lack of fusion at l5/ s1 vertebral body due to mechanical overload of the reduction pedicle screws. Fusion observed at l4-l5. All fragments of screws removed. No patient complications were reported as a result of this event.

 
Event Description

It was reported that the patient underwent a total laminectomy for decompression at l4-s1 and x-ray showed hardware fracture (2 reduction screws) with pseudoarthrosis at l5-s1 approximately 6-7 months postop.

 
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Brand NameORTHROS
Type of DeviceØ7.5MM POLYAXIAL REDUCTION PEDICLE SCREW , 40MM LG.
Manufacturer (Section D)
CAMBER SPINE TECHNOLOGIES
418 e. lancaster ave.
wayne PA 19087
Manufacturer (Section G)
CAMBER SPINE TECHNOLOGIES
418 e. lancaster ave
wayne PA 19087
Manufacturer Contact
marjorie ochroch
418 e. lancaster ave
wayne, PA 19087
4844277060
MDR Report Key7172457
MDR Text Key97491864
Report Number3010197239-2017-00001
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK`133366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 11/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberORO-7540R
Device Catalogue NumberORO-7540R
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 Received10/31/2017
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

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