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 Migration (4003)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pc: surgical intervention in the form of revision surgery.(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: no event outcome/how was it managed? screws were removed.New pilot holes created and replacement screws inserted.Mr (b)(6) was revising a previous fusion l2-s2ai with xlifs at l2/3, l3/4 and l4/5.The patient had pjk and therefore required revising (extension of fusion).The l2 screws had pulled out (subject of complaint) and hence needed revising.Screws were removed.New pilot holes created and replacement screws inserted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Visual examination of the screw revealed that the tulip head of the screw is stuck in a position.It was also noted that the initial thread of the tulip head was torn.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.With the information provided, a definitive root cause for the jammed tulip head on the 5.5 expedium verse fenestrated screw 6.0 x 45 cannot be determined.However, a potential root cause may have occurred due to exerting a significant amount of force on the tulip head and saddle, potentially at a significant angle, may have led to tulip head stuck in a position.With the information provided, a definitive root cause for the torn thread of the tulip head cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.It should be noted that tightening the setscrew when it is cross threaded places force on the setscrew and the tulip head¿s threads that can result in them being torn.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: 8174029
• MDR Text Key: 130659461
• Report Number: 1526439-2018-51154
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• 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: 01/31/2023
• Device Model Number: 199723645S
• Device Catalogue Number: 199723645S
• Device Lot Number: 181386
• 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: 02/10/2018
• 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