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	Nerve Damage (1979); Pain (1994); Hypoesthesia (2352)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
(b)(6) study subject (b)(6).It was reported patient has experienced the following: increase neck pain started after reading with stiffness then pain bilateral arm pain with heaviness, aching from shoulders to hand, radiates from neck per patient bilateral lower extremity numbness/tingling- has preexisting low back pain with radiculopathy right hand nerve pain-preexisting condition, has increased in intensity concomitant devices: vg1c-t57p (spacer), lot 171550-1032 (1), vg1c-t68p (spacer), lot 1713536-1035 (1), bl-1500-001 (pouch), lot 1714530-8029 (1).
Additional Manufacturer Narrative
(b)(4).Clinical study report 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: 7385162
• Report Number: 1526439-2018-50284
• Device Sequence Number: 19155501
• Product Code: KWQ
• UDI-Device Identifier: 10705034133799
• UDI-Public: (01)10705034133799
• Combination Product (Y/N): N
• 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): 03/02/2018

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: 03/02/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 03/30/2018
• 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: 54 YR
• Patient Weight: 110