MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS CANN POLY SCW 6X45MM,TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186715645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Spinal Column Injury (2081)
Date of Event	06/05/2018
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
The patient got 4 screws implanted on l5-s1 to treat a grade i symptomatic isthmic spondylolisthesis when adolescent.After some months, the segment appeared as fused on scanner.However patient practices ski jumps at competition level and felt discomfort with the implants.On radiography performed later on, one s1 screw appeared as broken at the level of the neck of the shank (bottom of screw head).Upon removing implants, both s1 screw necks were broken.Surgeon believes this is a due to the extreme constraints that the ski jump supposed on the implants.Patient consequence?: yes.Patient consequence description:the patient was feeling the implants and this created some discomfort.Action taken for procedure: removal of implants.Surgeon decided to leave the broken shafts in s1.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

• Brand Name: MIS CANN POLY SCW 6X45MM,TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7674228
• Report Number: 1526439-2018-50634
• Device Sequence Number: 13795412
• Product Code: NKB
• UDI-Device Identifier: 10705034122359
• UDI-Public: (01)10705034122359
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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: 186715645
• Device Catalogue Number: 186715645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/10/2018
• 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