MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY VARIABLE S-D SCW 14MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	186850014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Osteolysis (2377)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
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: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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
It was reported that patient underwent an anterior cervical discectomy and fusion acdf c4/5 with possible removal of the existing non-synthes cervical plate (c7) on (b)(6) 2022.During the procedure, the surgeon was using acis set to implant an acis pro ti cervical graft.The surgeon either had to use zero p at c4/5 or remove the plate to use acis and skyline.He ended up removing the plate and used acis and a skyline single-level plate.He inserted the implant and upon removal of the inserter realized it was too far.The patient partially lost motors from the chest down.There was no equipment malfunction.A variety of instruments were used to remove the spacer.A new graft was placed and the plate was implanted with screws.Procedure was completed with an unknown delay.The patient was taken to the icu and has not progressed very well.Once the case was completed, neuro monitoring showed that one side of the patient's body was getting some motor response while the other side was not.This report is for a sky variable s-d scw 14mm ti.This is report 4 of 6 for (b)(4).

• Brand Name: SKY VARIABLE S-D SCW 14MM 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
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17492533
• Report Number: 1526439-2023-01455
• Device Sequence Number: 20646269
• Product Code: KWQ
• UDI-Device Identifier: 10705034134086
• UDI-Public: (01)10705034134086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: 186850014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACIS PROTI 10 DG HL M 6 MM H.; ACIS PROTI 10 DG HL M 6 MM H.; SKY 1 LEVEL PLTE 14MM TI.; SKY VARIABLE S-D SCW 14MM TI.; SKY VARIABLE S-D SCW 14MM TI.; SKY VARIABLE S-D SCW 14MM TI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female