MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY 2 LEVEL PLTE 40MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186802040
Medical Device Problem Codes	Material Discolored (1170); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: 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 depuy synthes reports an event in (b)(6) as follows: it was reported that before using the product, the product was found with the problem of discoloration and had the sign of being ground, which looked very old.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) sky 2 level plte 40mm ti.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SKY 2 LEVEL PLTE 40MM 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 (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 14346900
• Report Number: 1526439-2022-00690
• Device Sequence Number: 4698083
• Product Code: KWQ
• UDI-Device Identifier: 10705034133720
• UDI-Public: (01)10705034133720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 186802040
• Device Catalogue Number: 186802040
• Device Lot Number: 246544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/10/2022
• 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
• Patient Sex: Unknown