MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY CONST S-D SCW 17MM TI; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	186860017
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patent identifier: (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 (b)(6) reports an event as follows: it was reported that on an unknown date, during the follow-up, the surgeon discovered that one of the screws has been pulled out.The patient had an acdf surgery using a skyline plate on (b)(6) 2020.It was unknown that the patient if schedule for further procedure.The patient outcome was unknown.Concomitant medical products: skyline plate (part# unknown, lot# unknown, quantity unknown).This complaint involves one device.This report is for one (b)(4).This report is one of one for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H4, h6: the dhr of product code 186860017, lot 266753, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on (b)(6) 2020.Qty.120 the dhr was electronically reviewed.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed as image shows a screw is pulled out of the plate.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.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.

• Brand Name: SKY CONST S-D SCW 17MM TI
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11081913
• Report Number: 1526439-2020-02489
• Device Sequence Number: 2694830
• Product Code: KWQ
• UDI-Device Identifier: 10705034134529
• UDI-Public: 10705034134529
• Combination Product (Y/N): N
• PMA/510(K) Number: K052552
• 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,Followup
• Report Date (Section B): 11/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186860017
• Device Catalogue Number: 186860017
• Device Lot Number: 266753
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PLATES
• Outcome Attributed to Adverse Event: Required Intervention