MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 50; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	199721650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procodes: kwp, kwq, mnh, mni, osh.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.(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 or Problem Description
Device report from the (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent revision surgery due to infection and sepsis leading to cage becoming dislodged.Surgeon removed posterior instrumentation, inserted alif cages and put new metalwork in posteriorly in third stage operation.All screws were removed, and biopsies taken of the pedicles.This report is for a 5.5 exp verse screw 6.0 x 50.This is report 7 of 7 for (b)(4).

• Brand Name: 5.5 EXP VERSE SCREW 6.0 X 50
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10038605
• Report Number: 1526439-2020-00936
• Device Sequence Number: 2813324
• Product Code: MNH
• UDI-Device Identifier: 10705034442266
• UDI-Public: (01)10705034442266
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 199721650
• Device Catalogue Number: 199721650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention