MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS APPLIANCE, FIXATION, SPINAL INTERLAMINAL; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 5440030

Device Problem Material Frayed (1262)

Patient Problem Pain (1994)

Event Date 01/05/2015

Event Type  Injury  

Event Description

"it was reported that a patient who had undergone a previous discectomy surgery and was still in pain, underwent a midlf procedure at l4-l5.During the procedure, the set screw was inserted into the screw and attempted to be provisionally tightened.The surgeon was not able to do this and on removing the set screw it looked visibly damaged with a sharp rough edge.No fragment of the implant was remaining in the patient.".

Manufacturer Narrative

(b)(4): neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Manufacturer Narrative

Analysis of the returned device shows that the truncated portion of the leading edge of the thread is damaged, with a piece of material appears to have been dragged with the mas thread, damaging the top flank of the thread.The localized damage at the start of the thread suggests misalignment when attempting to engage the set screw.

• Brand Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS; road 909, km. 0.4 bo. mariana; humacao PR 00792
• 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: 4394454
• MDR Text Key: 5303861
• Report Number: 1030489-2015-00069
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5440030
• Device Lot Number: H5146386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2014
• 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