MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number MSB_UNK_XLINK _X10

Device Problem Device Damaged by Another Device (2915)

Patient Problem Pain (1994)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from healthcare provider via manufacturing representative regarding patient with implant product which was fastened to t3-iliac was removed.Iliac part was the primary reason for buttock pain, so all was removed.Procedure used s5 was inserted into iliac screw was attempted for removal.Event occurred intra-op.It was reported that the tip of the reported driver was broken.There was osteosclerosis around the screw placement.Though the reported screw driver tip was broken the iliac skin was shaved and the screw was removed somehow, the original purpose was achieved.No device fragments left in patient.Additionally regarding the driver breakage, osteosclerosis around iliac screw was considered to be the reason, so the tip of screw driver was broken.The surgeon also consented to the occurrence of the event.No further patient symptoms or complications were reported.No health damage to patient.Devices will be returned.Update 2020-oct-29; the pe has been reported to have two drivers damaged during reoperation.However, this case has been re-operated, and the f4.75 rod was broken and the f5.5 rod was broken in this reoperation.It was reported that one of the set screws of the x10 cross link (fix type) installed on the f4.75 rod backed out and the arm of the x10 cross link (multi-span) was damaged.Therefore, added pli30 for f4.75 rods, pli40 for f5.5 rods, pli50 for x10 (4.75), and pli60 for x10 (5.5).Devices were discarded by customer.Pli70 was added for reoperation.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10807641
• MDR Text Key: 215975195
• Report Number: 1030489-2020-01612
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_XLINK _X10
• Device Catalogue Number: MSB_UNK_XLINK _X10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• 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