MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY 2 LEVEL PLTE 34MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186802034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	01/01/2018
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
(b)(6) stud: subject (b)(6): diagnosis: incision and debridement of anterior neck.He has noted a small of amount of ongoing scant yellowish drainage/spotting from his neck incision, which he usually notes on the pillow overnight.He states that this began several weeks ago after shaving.He has noted a small prominence near his incision, but denies any erythema or induration.He has weaned off narcotic pain medications, and takes tylenol as needed occasionally for pain.He completed a course of bactrim.He is making continued progress with resolution of pain symptoms and ongoing improvement in strength.He has had some spotting of serofibrinous appearing drainage from cervical incision which does have slight nodular appearance at central portion of incision.Small amount of purulent appearing drainage was expressed today which is near hair follicle and has appearance of small superficial inclusion cyst or ingrown hair.Performed lancing of cyst which was very superficial and had minimal additional drainage, but mostly bleeding.No tracking of pocket.Incision was redressed with 4x4 and tegaderm.Will continue daily dressing changes and plan for completion of additional week of abx.Will follow up in 2 weeks if continues to have issues with incision.Otherwise plan for follow up in 3 months or prn.Concomitant devices: bl-1500-001 vivigen (1); vg1c-t79p vertigraft vg1 cervical-7 degree lordosis preservon spacer 9.22 mm 7.75 mm (2).
Additional Manufacturer Narrative
(b)(4).Clinical study report received on 10/19/2018.Clinical study report log was reviewed.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 not related to the plate.As such, this is considered a non reportable event.

• Brand Name: SKY 2 LEVEL PLTE 34MM 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: 7569258
• Report Number: 1526439-2018-50526
• Device Sequence Number: 10814331
• Product Code: KWQ
• UDI-Device Identifier: 10705034133690
• UDI-Public: (01)10705034133690
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/10/2018

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: 186802034
• Device Catalogue Number: 186802034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 06/05/2018
• 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: 60 YR