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

Model Number	ORO-7540R
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: ORTHROS
• Common Device Name: Ø7.5MM POLYAXIAL REDUCTION PEDICLE SCREW , 40MM LG.
• Manufacturer (Section D): CAMBER SPINE TECHNOLOGIES; 418 e. lancaster ave.; wayne PA 19087
• MDR Report Key: 7172457
• Report Number: 3010197239-2017-00001
• Device Sequence Number: 16447009
• Product Code: NKB
• UDI-Device Identifier: B030ORO7540R0
• UDI-Public: B030ORO7540R0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K`133366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: ORO-7540R
• Device Catalogue Number: ORO-7540R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR