MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 80MM; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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 on (b)(6) 2020, the tulip broke off of the screw.The patient and procedure outcome were unknown.Concomitant devices: unknown rod (part# unknown, lot# unknown, quantity unknown).Unknown setscrew (part# unknown, lot# unknown, quantity unknown).This report is for one (1) fenestrated cortical fix polyaxial screw 5.5 x 8 x 80mm.This is report 1 of 1 for (b)(4).

• Brand Name: FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 80MM
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10904733
• Report Number: 1526439-2020-02278
• Device Sequence Number: 14121024
• Product Code: PML
• UDI-Device Identifier: 10705034282855
• UDI-Public: 10705034282855
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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: 186727880
• Device Catalogue Number: 186727880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention