MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 180MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179762480

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the rod was broken after dissection.Revision procedure was performed for the l1 screw and the rod was removed.New screws and rods were implanted.No surgical delay reported.Concomitant device reported: unknown locking/set screws (part# unknown, lot# unknown, quantity unknown), single-inner setscrew (part# 179702000, lot# unknown, quantity unknown) this report is for one (1) expedium spine system rod 5.5 x 480mm this is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11: b1, b5, h1: the initial complaint was reviewed and found not reportable.Additional information was received indicating there was no malfunction alleged against this device.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The initial complaint was reviewed and found not reportable.Additional information was received indicating there was no malfunction alleged against this device.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant device reported: unknown locking/set screws (part# unknown, lot# unknown, quantity unknown), expedium spine system rod 5.5 x 480mm (part# 179762480, lot# bdlf7sx, quantity 2), mis ti cfx fen poly 5x45 (part# 186727545, lot# arlcfz, quantity 2), mis ti cfx fen poly 6x50 (part# 186727650, lot# 115825, quantity 4), mis ti cfx fen poly 6x40 (part# 186727640, lot# 139797, quantity 2), mis ti cfx fen poly 6x45 (part# 186727645, lot# 152257, quantity 2), single-inner setscrew (part# 179702000, lot# unknown, quantity 3), single-inner setscrew (part# 179702000, lot# 159208, quantity 1), single-inner setscrew (part# 179702000, lot# 174234, quantity 1), single-inner setscrew (part# 179702000, lot# 159183, quantity 1), single-inner setscrew (part# 179702000, lot# 152708, quantity 1), single-inner setscrew (part# 179702000, lot# 163162, quantity 1), single-inner setscrew (part# 179702000, lot# 118297, quantity 2).This report is for one (1) expedium spine system rod 180mm.This is report 1 of 4 for (b)(4).

• Brand Name: ROD, 180MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10314760
• MDR Text Key: 207339896
• Report Number: 1526439-2020-01380
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077437
• UDI-Public: (01)10705034077437
• Combination Product (y/n): N
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179762480
• Device Catalogue Number: 179762180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Patient Sequence Number: 1
• Treatment: MIS TI CFX FEN POLY 5X45.; MIS TI CFX FEN POLY 6X45.; MIS TI CFX FEN POLY 6X50.; ROD, 480 MM.; ROD, 480 MM.; ROD, 480 MM.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; UNKNOWN SCREWS.; UNKNOWN SCREWS.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 100