MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY 3 LEVEL PLTE 48MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186803048
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
Vivigen: it was reported that an adverse event of burning pain over posterior spine.Study subject 18-007.Concomitant medical products: bl-1500-001, vivigen pouches 1cc, qty 2, 77101074, bio avs c-open 4=14(w) x 12(d), qty 2, 77101064, bio avs c-open 4= h=6mm 4= lordosis.
Additional Manufacturer Narrative
(b)(4).Study report was received on 10/19/2018.Report states that the event is not considered to be a serious adverse event.The issue is not life threatening.The patient did not experience disability or permanent damage.There was no required intervention to prevent permanent impairment or damage.It has been determined that the event is unlikely related to the plate.As such, this is considered a non reportable event.

• Brand Name: SKY 3 LEVEL PLTE 48MM 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: 7606513
• Report Number: 1526439-2018-50561
• Device Sequence Number: 275096
• Product Code: KWQ
• UDI-Device Identifier: 10705034133799
• UDI-Public: (01)10705034133799
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 186803048
• Device Catalogue Number: 186803048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 94