MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5MM X 35MM FACET SCREW; SYSTEM, FACET SCREW SPINAL DEVICE

Model Number	175710535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).(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
Depuy synthes received a voice mail from (b)(6) sales rep, reporting that during a laminectomy procedure on (b)(6) 2018 metal pieces of device (b)(4) broke off in the patient.He stated that this came from the teeth.The surgery was completed successfully and patient was not harmed.The surgeon was upset that this occurred.Synthes created (b)(4) for the documentation of this complaint.

• Brand Name: 5MM X 35MM FACET SCREW
• Common Device Name: SYSTEM, FACET SCREW SPINAL DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7869937
• Report Number: 1526439-2018-50876
• Device Sequence Number: 19166956
• Product Code: MRW
• UDI-Device Identifier: 10705034034812
• UDI-Public: (01)10705034034812
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 175710535
• Device Catalogue Number: 175710535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1