MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY 1 LEVEL PLTE 22MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186801022
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, it was found that there was no product code on the label of the plate before it was used on the patient in a cervical spondylosis procedure.Another one was used to complete the surgery.There was no patient consequence reported.This report is for a skyline one level plate, 22mm.This is report 1 of 1 for (b)(4).

• Brand Name: SKY 1 LEVEL PLTE 22MM 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: 10448319
• Report Number: 1526439-2020-01520
• Device Sequence Number: 3558308
• Product Code: KWQ
• UDI-Device Identifier: 10705034133591
• UDI-Public: (01)10705034133591
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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: 186801022
• Device Catalogue Number: 186801022
• Device Lot Number: 245712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/25/2020
• Patient Sequence Number: 1