MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199723645S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The following was reported, the screw was removed and a larger diameter (7x40) was inserted in its place.The l3 screw was present from a previous fusion: l2-s2ai with xlifs at l2/3, l3/4 & l4/5.The screw was removed and it became clear the tip of the screw had snapped due to the subsidence of the titanium cage above at the 2/3 disc space.In subsiding the cage had collided with the screw and broken it.This was highlighted to mr (b)(6) and as the broken fragment was some way into the vertebral body he opted to leave it in situ inserting a shorter screw with a wider diameter to avoid hitting the fragment.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The screw was found to have broken at the base of the shank.Fracture analysis was subsequently performed on the screw.Optical imaging of the fracture site shows two surface morphologies, a smooth region and a rough region that are indicative of fatigue failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the screw breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a potential root cause may be fatigue failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X45
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8173778
• MDR Text Key: 130646431
• Report Number: 1526439-2018-51152
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034443515
• UDI-Public: (01)10705034443515
• Combination Product (y/n): N
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 199723645S
• Device Catalogue Number: 199723645S
• Device Lot Number: AVDCV3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention