MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC AXIS FIXATION SYSTEM; SCREW, FIXATION, BONE

Model Number 870-214

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

Patient Problems Purulent Discharge (1812); Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professor via manufacturer representative regarding patient with unknown symptoms involved in posterior cervical fusion procedure used in spinal therapy, levels implanted: c3-c6.It was reported after the operation, there was something like a tumor on the odontoid process, and the fusion was additionally extended from oc to t5.There was no delay in overall procedure time.Reported there is no malfunction of the product.On 2020-sep-24, received additional information that reoperation was performed on (b)(6) 2020, fusion on oc-t5 was performed, and operation was completed without problems (no malfunction or adverse event occurred).Reported in the patient mass was like pus.

• Brand Name: AXIS FIXATION SYSTEM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10625127
• MDR Text Key: 209765521
• Report Number: 1030489-2020-01364
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 870-214
• Device Catalogue Number: 870-214
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2020
• 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 Outcome(s): Required Intervention