MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY VARIABLE S-D SCW 15MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186850015
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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 the surgeon performed a anterior cervical discectomy and fusion (acdf) case in (b)(6) 2020 using cervios & skyline plate.On an unknown date, two (2) screws migrated and began causing pain to the patient.They were removed in a revision case performed on (b)(6) 2020.The surgeon replaced them with another two (2) rescue screws.There is no further information available.The patient outcome is unknown.Concomitant device reported: unknown cage(part# unknown, lot# unknown, quantity unknown ); unknown skyline plate (part# unknown, lot# unknown, quantity unknown ).This report is for one (1) sky variable s-d scw 15mm ti.This is report 1 of 2 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.H10 additional narrative: h3, h6: 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
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.H10 additional narrative: h3, h4, h6 three x-ray images were provided: two from (b)(6) 2020 after the initial surgery, and one lateral view dated (b)(6) 2020 indicating one screw had backed out.It will be conservatively assumed two screws had backed out.No other issues were noted.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The complaint condition was confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot - the dhr of product code: 186850015 lot : 284700.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 11.08.2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
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.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 VARIABLE S-D SCW 15MM 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: 10984134
• Report Number: 1526439-2020-02387
• Device Sequence Number: 19641929
• Product Code: KWQ
• UDI-Device Identifier: 10705034134093
• UDI-Public: (01)10705034134093
• Combination Product (Y/N): N
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• 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): 11/13/2020

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: 186850015
• Device Catalogue Number: 186850015
• Device Lot Number: 284700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 12/17/2020; 01/15/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 12/18/2020; 12/18/2020; 01/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SKY VARIABLE S-D SCW 15MM TI.; UNKNOWN CAGE/SPACER.; UNKNOWN SKYLINE PLATE.; SKY VARIABLE S-D SCW 15MM TI; UNKNOWN CAGE/SPACER; UNKNOWN SKYLINE PLATE
• Outcome Attributed to Adverse Event: Required Intervention