MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DI POLYAXL SCRW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179722640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional product code: 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.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient had suffered from the adjacent disease.On (b)(6) 2021 a revision surgery was performed without further issue.The primary procedure was performed in 2008 and expedium di was applied.This complaint involves twenty (20) devices.This report involves one (1) exp di polyaxl scrw 6 x 40mm this is report 11 of 20 for (b)(4).

• Brand Name: EXP DI POLYAXL SCRW 6 X 40MM
• Common Device Name: 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: 12373708
• Report Number: 1526439-2021-01771
• Device Sequence Number: 13764266
• Product Code: NKB
• UDI-Device Identifier: 10705034070629
• UDI-Public: 10705034070629
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2010
• 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): 07/30/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 179722640
• Device Catalogue Number: 179722640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP DI POLYAXL SCRW 6 X 40MM; EXP DI POLYAXL SCRW 6 X 40MM; EXP DI POLYAXL SCRW 6 X 40MM; EXP DI POLYAXL SCRW 6 X 40MM; EXP DI POLYAXL SCRW 6 X 40MM; EXP DUAL-INNER SETSCREW; EXP DUAL-INNER SETSCREW; EXP DUAL-INNER SETSCREW; EXP DUAL-INNER SETSCREW; EXP DUAL-INNER SETSCREW; EXP DUAL-INNER SETSCREW; LUMBAR I/F CAGE 9 X 21MM; LUMBAR I/F CAGE 9 X 21MM; LUMBAR I/F CAGE 9 X 21MM; LUMBAR I/F CAGE 9 X 21MM; LUMBAR I/F CAGE 9 X 21MM; ROD, 120MM; ROD, 120MM; ROD, 480 MM; TI TRANSVERSE CONNECTOR
• Outcome Attributed to Adverse Event: Required Intervention