MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK MICHELSON; DANEK SOLERA/BACK RODS

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/02/2016

Event Type  Injury  

Event Description

Metal rods insert in back (b)(6) 2016 and broke in (b)(6) 2016 another set road inserted in (b)(6) 2016 and broke again and maybe another set to be inserted in (b)(6) 2018.Serial number of first rods (b)(4), second set of rods serial number (b)(4).Mfg: medtronic-danek solera.

• Brand Name: MICHELSON
• Type of Device: DANEK SOLERA/BACK RODS
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK
• MDR Report Key: 7142068
• MDR Text Key: 95750664
• Report Number: MW5074173
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/20/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91