MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	179712750
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional 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.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 (b)(6) reports an event as follows: it was reported that on july 20, 2021, patient underwent revision surgery due to pull-out of two screws.During the procedure, there was a small cement leakage in the canal during the introduction of the confidence cement.Radiologically, the cement did not come out of the holes on the implanted screw.This report is for a si polyaxl screw 7 x 50mm.This is report 2 of 2 for (b)(4) and captures the required revision surgery.The cement leakage is captured under (b)(4).

• Brand Name: SI POLYAXL SCREW 7 X 50MM
• 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: 12338856
• Report Number: 1526439-2021-01723
• Device Sequence Number: 4686817
• Product Code: NKB
• UDI-Device Identifier: 10705034067919
• UDI-Public: (01)10705034067919
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179712750
• Device Catalogue Number: 179712750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/18/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SI POLYAXL SCREW 7 X 50MM
• Outcome Attributed to Adverse Event: Required Intervention