MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported in an article entitled ¿quality of life and radiological outcome after cervical cage fusion and cervical disc arthroplasty¿, a study to compare the clinical and radiological outcomes of two techniques for single-level cervical radiculopathy; fusion with cage filled with hydroxyapatite paste and cervical disc arthroplasty.Between january 2006 and october 2009, 57 patients underwent anterior cervical discectomy for single-level cervical spine disease.Forty-two out of the 57 patients were available for follow up.The cage group consisted of 23 patients (13 males, 10 females) and the cervical disc arthroplasty group consisted of 19 patients (9 males, 10 females).Mean age at time of surgery was 50 years old.Mean follow up was 17.5 months.None of the patients had undergone previous cervical surgery.It was reported that swallowing difficulty was experienced in 6 of the cage patients and 4 of the disc patients.Hyperaesthesia was noted in 2 cage patients and 1 disc patient.Subsidence was noted in 6 cage patients and 2 disc patients, none of the cases required revision as there were no clinical symptoms.Painful adjacent level disease was noted in 2 cage patients which required arthroplasty.

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.

• Brand Name: UNK
• 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: 4338277
• MDR Text Key: 5203875
• Report Number: 1030489-2014-04771
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/26/2014

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/17/2014
• 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