MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 10X40; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	03/05/2018
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
Revision, l5 screw (left) removal and pedicle subtraction dr (b)(6), (b)(6) private (b)(6) 2018.Primary implant date: (b)(6) 2015 dr (b)(6), (b)(6) private.First revision (b)(6) 2016 cf 5098185/(b)(4).Second revision (b)(6) 2016 cf 5098188/(b)(4).Third revision (b)(6) 2016 cf 5098030/(b)(4).Fourth revision (b)(6) 2018 revision for broken rods - dr (b)(6), (b)(6) private patient re-operated on to replace bilateral broken rods and loosening of 3 screws in lower section of construct l4- pelvis, below inline connectors.All set screws,rod connectors,three larger diameter screws and two rods replaced replace below connection point of upper construct.Fifth revision (b)(6) 2018 dr (b)(6), (b)(6) private.Patient complaining of l5 left sided foraminal pain after revision surgery (b)(6) 2018.Patient returned to theatre and had : sfx crossconnector, set screws, rod to rod connectors and rods removed from left side.Left l5 10 mm cfx screw was then removed (discarded)and pedicle osteotomy performed.Sfx crossconnector, set screws, rod to rod connectors, rods were replaced and final tightened.(b)(6).

• Brand Name: MIS TI CFX FEN POLY 10X40
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7382198
• Report Number: 1526439-2018-50277
• Device Sequence Number: 16452112
• Product Code: PML
• UDI-Device Identifier: 10705034282336
• UDI-Public: (01)10705034282336
• Combination Product (Y/N): N
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2018

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: 186727040
• Device Catalogue Number: 186727040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 03/29/2018
• 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: Required Intervention