MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)

Catalog Number	03.70.055
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 august 2018; lot 1620085: (b)(4) items manufactured and released on 26 july 2016 expiration date: 2021-07-12 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complainant of pain 3 months after primary: the screw had broken.It is unknown if the patient will be revised at all.Update jul 31, 2018 from the agent: the surgeon is planning on revising this patient but is not going to go anterior, surgeon is going to elect to just go posterior and add some screws and rods.
Additional Manufacturer Narrative
On october 15, 2018 no additional information will be obtained about this case.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 14 september 2018 few months after surgery the patient was complaining about pain.One of the screws was found to be broken.We cannot establish from the documentation provided if tbone fusion took place or not yet the documentation is not sufficient to enable a proper evaluation of potential clinical causes for this episode.

• Brand Name: CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)
• Common Device Name: VARIABLE SELF-TAPPING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7793274
• Report Number: 3005180920-2018-00609
• Device Sequence Number: 1249413
• Product Code: KWQ
• UDI-Device Identifier: 07630030840333
• UDI-Public: 07630030840333
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2018

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 Expiration Date: 07/12/2021
• Device Catalogue Number: 03.70.055
• Device Lot Number: 1620085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 07/19/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/14/2018; 11/14/2018
• 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: Other