MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR F/A SCREW 3.5X22; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188318322
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).No plan of surgical intervention at the moment.Broken hardware post-op will likely result in the need for revision surgery.(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
It was reported that the construct was c4-c7 posterior spine fusion.Patient had acdf c4-7 12 months prior to posterior surgery.Dr.Noticed c7 left screw is broken inside vertebrae during 6mo follow up x-rays.Implant is a mountaineer 3.5 x 22mm f/a screw broken in c7.Surgeon plan is to order a ct for the patient and make a plan from there.

• Brand Name: MNTR F/A SCREW 3.5X22
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7996608
• Report Number: 1526439-2018-51003
• Device Sequence Number: 1301847
• Product Code: NKG
• UDI-Device Identifier: 10705034157221
• UDI-Public: (01)10705034157221
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 188318322
• Device Catalogue Number: 188318322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/23/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR