MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY 4 LEVEL PLTE 64MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186804064
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
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
It was reported that the skyline plate cam lock was not engaging correctly at c3 on the left.Upon inspection, the rep noticed that it was possible, given the angle in relation to the plate, the cam lock may not be engaging correctly with the head of screw.Rep recommended to surgeon to return the cam to its neutral position and back out the screw by 2mm or replace the screw with one that was 2mm longer.Both solutions goal was to the have to screw head at an adequate height to successfully engage with the cam lock mechanism.Surgeon decided to back the original screw out by 2mm.He then tried to re-engage the locking mechanism.The cam lock spun beyond it¿s locking zone, was ¿loose¿ and now was at a pronounced height compared being flush with the plate.The conclusion was drawn that the cam lock mechanism was broken.At this point, the surgeon decided to delicately return the cam to neutral and tactically confirm screw purchase at c3 on the left (the broken cam in question).He stated that the risk of removing the entire constructs screws, replacing the plate and re-screwing with oversized rescue screws could potentially create bigger issues than leaving the construct the way it was with the current broken locking mechanism.Surgeon mentioned he planned on backing up the patient the following week, which was a procedure he already planned on performing prior to the malfunction.This would potential alleviate the load on the c3/left screw.Levels: c3-c7.Initial plan: c3-c7.Final: c3-c7.

• Brand Name: SKY 4 LEVEL PLTE 64MM 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: 8287184
• Report Number: 1526439-2019-51287
• Device Sequence Number: 16748701
• Product Code: KWQ
• UDI-Device Identifier: 10705034133881
• UDI-Public: (01)10705034133881
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186804064
• Device Catalogue Number: 186804064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/29/2019
• 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