MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	199723745S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
Spinal fixation or spondy grade 2 l4-5 6 months after surgery the treating physician noticed that one screw was broken.All locking caps were tightened according to the surgical technique and double checked during surgery for correct torque locking.The screw breakage has occurred in the months after the surgery.The surgery itself was successful and no postoperative events have occurred that might explain the screw breakage.The patient was treated for a spondy grade 2 at level l4-5.Primary surgery date (b)(6) 2017.No other patient data is available.

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X45
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7756355
• Report Number: 1526439-2018-50744
• Device Sequence Number: 1230734
• Product Code: NKB
• UDI-Device Identifier: 10705034444505
• UDI-Public: (01)10705034444505
• Combination Product (Y/N): N
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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 Expiration Date: 07/31/2021
• Device Model Number: 199723745S
• Device Catalogue Number: 199723745S
• Device Lot Number: AVKBZ6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/07/2018
• 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: Required Intervention
• Patient Age: 52 YR