MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY VARIABLE S-D SCW 18MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186850018S
Medical Device Problem Code	Break (1069)
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.Reporter is a j&j employee.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 an unknown date, the sky variable self-drilling screw broke.The screw was originally implanted in the patient on an unknown date in 2009.The revision surgery was performed on (b)(6) 2021.The procedure outcome is unknown.There is no further information available.This report is for one (1) sky variable s-d scw 18mm ti.This is report 1 of 1 for (b)(4).

• Brand Name: SKY VARIABLE S-D SCW 18MM 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: 12410561
• Report Number: 1526439-2021-01806
• Device Sequence Number: 12012654
• Product Code: KWQ
• UDI-Device Identifier: 10705034412412
• UDI-Public: 10705034412412
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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: 186850018S
• Device Catalogue Number: 186850018S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 09/01/2021
• Patient Sequence Number: 1
• Patient Age: 47 YR