MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable imaging films were returned to manufacturer therefore cause of event cannot be determined.

Event Description

It was reported that on (b)(6) 2015, patient underwent posterior fixation at levels l2-l5 after performing oblique lateral interbody fusion (olif) at the same levels to treat degenerative scoliosis.Intra-op, foreign small metal debris were found on incision when surgeon tried to close incision after performing posterior fixation.The surgeon removed them by tweezers but reported that "the debris out of his visibility may be left in the patient".The event delayed surgical time within 15 minutes.The origination of the metal fragment was reportedly unknown.No patient complications were reported.It was reported that an inspection of the instruments confirmed no problem and there was no evidence that would suggest where the metal fragments came from.It seems that the most likely root cause of the metal fragments is the implant.

Manufacturer Narrative

Additional information.

Event Description

Metal debris was confirmed at l5 on the left side and l3/5 on the right.Compression was conducted only on the left.The incised part was irrigated,but the metal debris can still be inside, and they have not been retrieved yet.

• 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: 5199920
• MDR Text Key: 30327835
• Report Number: 1030489-2015-02899
• Device Sequence Number: 1
• Product Code: MAX
• 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: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• 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
• Date Manufacturer Received: 10/16/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00086 YR