MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

It was reported in an article entitled ¿spinopelvic fixation with iliosacral screws in neuromuscular spinal deformities: results in a prospective cohort of 62 patients¿ that from november 2005 to june 2007, all the patients undergoing a spinopelvic fixation with iliosacral screws for a neuromuscular spinal deformity were prospectively included in a computerized database.Sixty-two patients were operated on during the inclusion period.Forty-two patients were operated on using the cd horizon legacy spinal system (medtronic, (b)(4) usa) and 20 patients were operated on using the pivot link universal system-plus instrumentation ((b)(4)).No differences were noted between these two instrumentations regarding the spinal fixation.Post¿op infections with wound debridement were noted in 13 patients.Chronic staph infection and hardware removal was noted in 1 patient and screw migration with revision was noted in 5 patients.

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4367918
• MDR Text Key: 15820395
• Report Number: 1030489-2014-04868
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 12/29/2014
• 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