MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179762480

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: additional product code: osh, nkb, mnh, mni, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.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.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: on (b)(6) 2016 the patient underwent the primary procedure for correcting degenerative scoliosis.The expedium was applied.As the scoliosis progressed, the rod deployed on the distal side had started making contact with the skin.The patient underwent the revision procedure on an unknown date, and the surgeon cut the rod and removed the screw.No product defectiveness was found.This report is for one (1) expedium spine system rod 5.5 x 480mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM
• 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: 12373997
• MDR Text Key: 268351936
• Report Number: 1526439-2021-01775
• 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
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 179762480
• Device Catalogue Number: 179762480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention