MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-DRILLING SCREW 4 X 16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186860016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes 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.(b)(4).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 on an unknown date that there was a request for manufacturing documents related to complaint (b)(4).The complaint is for metal abrasion against the metal implants that were implanted with peek spacers.This report is for one (1) skyline anterior cervical plate system constrained self-drilling screw 4 x 16 mm.This is report 4 of 9 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.H10 additional narrative: 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.H10 additional narrative: h3, h4, h6 investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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 history the device has not been returned and the lot # provided cannot be verified , therefore, a dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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 CONSTRAINED SELF-DRILLING SCREW 4 X 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: 10224543
• Report Number: 1526439-2020-01289
• Device Sequence Number: 14010212
• Product Code: KWQ
• UDI-Device Identifier: 10705034134512
• UDI-Public: 10705034134512
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 186860016
• Device Catalogue Number: 186860016
• Device Lot Number: 158743
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 08/18/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/13/2020; 08/25/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SKY 3 LEVEL PLTE 51MM TI.; SKY CONST S-D SCW 16MM TI.; SKY CONST S-D SCW 18MM TI.; SKY CONST S-D SCW 18MM TI.; SKY CONST S-D SCW 18MM TI.; SKY VARIABLE S-D SCW 16MM TI.; SKY VARIABLE S-D SCW 16MM TI.; SKY VARIABLE S-D SCW 18MM TI.
• Outcome Attributed to Adverse Event: Required Intervention