MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 12MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186801012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Device report from synthes reports an event in (b)(6) as follows: it was reported that the skyline plate that was implanted on (b)(6) 2020, needed to be removed and revised.Revision surgery was performed on (b)(6) 2020.No further information was provided.This report is for one (1) skyline anterior cervical plate system one level plate 12mm.This is report 1 of 5 for (b)(4).

• Brand Name: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 12MM
• 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: 11147539
• Report Number: 1526439-2021-00119
• Device Sequence Number: 3494526
• Product Code: KWQ
• UDI-Device Identifier: 10705034133546
• UDI-Public: (01)10705034133546
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171439
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186801012
• Device Catalogue Number: 186801012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/11/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention