MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY VARIABLE S-D SCW 14MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186850014
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	01/01/2018
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
The patient provided the following information: since the revision, patient still is experiencing on-going pain.Ct scan taken in (b)(6) 2018 show radiolucency around the left c5-c6 screws.The patient states that the ct scan report indicates a linear lucency extending from the superior endplate of the left c5 vertebrae continuous with the anterior cervical screw at c5.Patient also stated two of the four screws were placed "crooked".And now she has a fracture at c5.There has been no further treatment or revision of the c5-c6 posterior cervical fusion.The patient has had no further contact, examination, or treatment with the implant surgeon.Patient stated no other surgeon will perform the revision.She is going to seek another opinion at cleveland clinic.Date unknown.Patient previously phone in complaint on (b)(6) 2018.Reported products were: 04.614.014; 04.614.508.Synthes complaint number (b)(4).
Additional Manufacturer Narrative
(b)(4).Investigation was conducted and did not yield any new relevant information.This follow up is being filed for additional information regarding explant date and correction regarding (reporter also sent report to fda).Maude report number mw5073583-1.

• Brand Name: SKY VARIABLE S-D SCW 14MM 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: 7789859
• Report Number: 1526439-2018-50803
• Device Sequence Number: 16728475
• Product Code: KWQ
• UDI-Device Identifier: 10705034134086
• UDI-Public: (01)10705034134086
• Combination Product (Y/N): N
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186850014
• Device Catalogue Number: 186850014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR