MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186801016
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 during the final tightening of the camloc of the plate, the upper right camloc screw hole went defective.The surgeon first turned the camloc to the left (counterclockwise) to lock it.The specified screwdriver did not show any defect after inspection.This report is for one (1) skyline anterior cervical plate system one level plate 16mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The implant(s) was not returned, and the investigation will be completed based on the supplied image(s) located in pc's attachments section received through 27apr2021.The image(s) was reviewed, and the picture the top right cam lock broke and as described in the event description the surgeon turned the camlock counterclockwise to lock it, which is the incorrect technique to do so, as the technique guide cr18-20-001 states: rotate the cam tighteners clockwise and do not rotate the cam past 270°.Turning the lock counterclockwise may have led to breaking and in turn led to the screw hole to become defective and therefore the condition is confirmed due to surgical technique.As the implant(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was performed and no issues were noted.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: the dhr of product code: 186801016.Lot : 267265.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 09.01.2020 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 16MM
• 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: 11855201
• Report Number: 1526439-2021-01009
• Device Sequence Number: 14498318
• Product Code: KWQ
• UDI-Device Identifier: 10705034133560
• UDI-Public: 10705034133560
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2021

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: 186801016
• Device Catalogue Number: 186801016
• Device Lot Number: 267265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 07/21/2021; 07/22/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/21/2021; 08/16/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPRESSOR; COMPRESSOR; SKY CAM TIGHTENER SHAFT; COMPRESSOR