MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY 1 LEVEL PLTE 26MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186801026
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
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
It was reported that on (b)(6) 2021, during anterior spinal fusion surgery when final tightening the cam lock on the skyline plating system, the cam did not engage the screw and continued to spin.The doctor concern was that the screw could potentially back out.There was a surgical delay of twenty (20) minutes.Patient status is unknown.The procedure was successfully completed.This report is for one (1) skyline anterior cervical plate system one level plate 26 mm this is report 1 of 2 for complaint (b)(4).

• Brand Name: SKY 1 LEVEL PLTE 26MM 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: 11952324
• Report Number: 1526439-2021-01151
• Device Sequence Number: 4243042
• Product Code: KWQ
• UDI-Device Identifier: 10705034133614
• UDI-Public: (01)10705034133614
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: 186801026
• Device Catalogue Number: 186801026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/07/2021
• Patient Sequence Number: 1
• Patient Age: 69 YR