MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKYLINE ANTERIOR CERVICAL PLATE SYSTEM; BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE

Model Number 186862012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

It was reported that on (b)(6) 2019, the patient underwent an anterior cervical discectomy and fusion (c6-c7) surgery.Post-surgery, the patient has developed some skin condition and is currently undergoing extended skin patch testing to rule out if the patient is not allergic to any of the metals that were placed into the patient's neck.The surgeon and dermatologist performed extended patch testing and vanadium chloride came back positive out of 80 common patches after 48 hours after surgery.Monitoring with allergists and dermatologists, working together to potentially prescribe medications.The surgeon will discuss whether or not a revision will be necessary after fusion.The patient was implanted with a plate from depuy spine, one screw is from depuy synthes and another one screw is from (b)(6) and a cage from depuy spine.Concomitant device reported: unknown screws (part#: unknown, lot#: unknown, quantity 2).This complaint involves six (6) devices.This report is 6 of 6 for (b)(4).

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.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
• Type of Device: BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9728862
• MDR Text Key: 192397289
• Report Number: 1526439-2020-00595
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10705034134581
• UDI-Public: 10705034134581
• Combination Product (y/n): N
• PMA/PMN Number: K052552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 186862012
• Device Catalogue Number: 186862012
• Device Lot Number: H87027A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Patient Sequence Number: 1
• Treatment: BENGAL IMPLANT STD 5MM 7 DEG; QTY 2; QTY 2; SKY 1 LEVEL PLTE 14MM TI
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 58