MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY 3 LEVEL PLTE 66MM TI; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	186803066
Medical Device Problem Codes	Corroded (1131); Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review /investigation.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 on an unknown date, the sky 3 level plate was found to have discoloration and corrosion.The procedure was completed using another plate.There was no patient consequence.There is no further information available.This report is for one (1) sky 3 level plte 66mm ti.This is report 1 of 1 for (b)(4).

• Brand Name: SKY 3 LEVEL PLTE 66MM 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: 11845912
• Report Number: 1526439-2021-00984
• Device Sequence Number: 4545996
• Product Code: KWQ
• UDI-Device Identifier: 10705034133850
• UDI-Public: 10705034133850
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186803066
• Device Catalogue Number: 186803066
• Device Lot Number: 152277
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1