MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY VARIABLE S-D SCW 16MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186850016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Foreign Body In Patient (2687); No Code Available (3191)
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
Patient for revision surgery after spondylodesis c4/5 with autologues bone graft and skyline plate on (b)(6) 2018.Current revision surgery because of persisting pain in neck and arms.Unclear if low grade infect, non union in radiology.During implant removal, it was found, that one of the skyline screws in c5 was broken.The tip of the screw was left in the vertebral body because it was impossible to remove.Surgery went on as planned and a longer plate was implanted.Removed implants were send for sonification and will not be available for examination.Was surgery delayed due to the reported event? --> no, action taken when event occurred? --> none, screw tip was left in place, was procedure successfully completed? --> yes, were fragments generated? --> unknown, if yes, were they removed easily without additional intervention? --> no, patient status/ outcome / consequences --> unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, other information --> patient has a strong nickel allergy and was intensively tested for other kinds of allergy like tan, tav, ticp before primary surgery.None of them could be confirmed., is the patient part of a clinical study --> no.Concomitant device reported: unknown plate (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.

• Brand Name: SKY VARIABLE S-D SCW 16MM 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: 9104494
• Report Number: 1526439-2019-52125
• Device Sequence Number: 1783073
• Product Code: KWQ
• UDI-Device Identifier: 10705034134109
• UDI-Public: (01)10705034134109
• Combination Product (Y/N): N
• PMA/510(K) Number: K052552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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: 186850016
• Device Catalogue Number: 186850016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/23/2019
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 48