MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188342200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); 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.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 that on an unknown date that the patient underwent the removal of a spine construct that was initially implanted on (b)(6) 2020 due to infection.The patient was placed in a brace following the procedure.The patient has poor bone quality and terminal cancer.This report is for one (1) mountaineer oct spinal system inner screw 3.5.This is report 8 of 10 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.H10 additional narrative: e1: updated.H3, h6: a product investigation was conducted: removal of a spine construct due to infection.Patient placed in a brace following procedure.Patient has poor bone quality and terminal cancer.Primary surgery was on the (b)(6) 2020.Customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s) from the attachment(s) located in notes & attachments section of the product complaint.The image(s) was reviewed, and no issues were noted with the implant(s) that would contribute to the adverse event and therefore is unconfirmed.As the implant(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed, as the lot number could not be determined from the images provided.There is no indication that a design or manufacturing issue contributed to the complaint as it was unconfirmed.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 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: MOUNTAINEER OCT SPINAL SYSTEM INNER SCREW 3.5
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10191674
• Report Number: 1526439-2020-01257
• Device Sequence Number: 3016383
• Product Code: NKG
• UDI-Device Identifier: 10705034158693
• UDI-Public: 10705034158693
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: 188342200
• Device Catalogue Number: 188342200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention