MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 6X50; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727650
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 three (3) weeks post op it was observed an biper inner set screw loosening on the x-ray.The set screw was lost from the screw and the construct needed to be revised.Patient was initially implanted on (b)(6) 2019.Revision surgery was performed on (b)(6) 2019.This is report 1 of 3 for complaint (b)(4).
Additional 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.Additional narrative: device history (lot), product code: 186727650, lot #: 230626.Device history review, the dhr of product code 186727650, lot 230626, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on (b)(6) 2019.Visual inspection of the implant showed no issues with the screw, no damage was noted.Review of the x-rays provided (3 images from the attachment(s) located in notes & attachments section of the product complaint); showed that the set screw separated from the screw resulting in the screw loosening from the rod.Functional test: the complaint condition could not be replicated as the set screw was able to be tightened with the screw and did not become loose.Conclusion: the complaint condition of is confirmed.No new issues were identified on the remaining portions of the device.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed 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
3 weeks post op it was observed an biper inner set screw loosening on the x-ray, the set screw was lost from the screw and the construct needed to be revised.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).This complaint involves three (3) devices.
Additional 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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: MIS TI CFX FEN POLY 6X50
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9396644
• Report Number: 1526439-2019-52525
• Device Sequence Number: 2851775
• Product Code: PML
• UDI-Device Identifier: 10705034282572
• UDI-Public: (01)10705034282572
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2019

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: 186727650
• Device Catalogue Number: 186727650
• Device Lot Number: 230626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 12/20/2019; 01/20/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/23/2019; 12/24/2019; 01/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention