MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ANCHOR FS? FACET SCREW; SYSTEM, FACET SCREW SPINAL DEVICE

Catalog Number PFF0040

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that a patient underwent a l5-s1 revision tlif in which a percutaneous reduction system was utilized on one side of l5-s1 and a facet fixation system screw on the other.Approximately one month post-op, the patient complained of pain at a follow up visit and it was discovered that the facet screw had broken.The physician stated there was no traumatic event that precipitated the event.A revision surgery was performed 52 days post-op and pedicle screws were implanted at l5-s1 on the side of the broken facet screw.According to the report, the physician elected to not remove the broken facet screw as it was believed to be too difficult and would cause too much stress at that level.No further patient complications were reported.

Manufacturer Narrative

(b)(4).X-ray interpretation: "image shows the screw across the l5/s facet with the screw broken within the joint space.".

• Brand Name: ANCHOR FS? FACET SCREW
• Type of Device: SYSTEM, FACET SCREW SPINAL DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3701254
• MDR Text Key: 21997205
• Report Number: 1030489-2014-01961
• Device Sequence Number: 1
• Product Code: MRW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFF0040
• Device Lot Number: 2313551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2012
• 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
• Treatment: PEDICLE SCREWS
• Patient Outcome(s): Required Intervention