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

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.

• Brand Name: ORTHROS
• Type of Device: Ø7.5MM 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 Key: 7172457
• MDR Text Key: 97491864
• Report Number: 3010197239-2017-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: B030ORO7540R0
• UDI-Public: B030ORO7540R0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K`133366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Model Number: ORO-7540R
• Device Catalogue Number: ORO-7540R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 01/08/2018
• 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 Sequence Number: 1
• Patient Age: 57 YR