MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK UNKNOWN ROD

Device Problem Break (1069)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4): neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be d etermined.

Event Description

It was reported that the patient underwent posterior spinal fixation at l1/5 levels to treat l3 burst fracture on an unspecified date.It was confirmed post-op that rods on both cranial sides at l5 was broken.The surgeon decided to remove the broken rods because of bone union achieved at l3 at which burst fracture occurred, not because of the breakages.The product was used in a patient.No patient complications were reported.Surgeon's comment: the event has no problem as bone union was achieved at l3.

Manufacturer Narrative

(b)(4).

• Brand Name: UNKNOWN ROD
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5158611
• MDR Text Key: 28912695
• Report Number: 1030489-2015-02714
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• 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,Followup
• Report Date: 09/30/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 10/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 00060 YR