MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	186770145
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: osh, mnh, kwq, mni, nkb.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that, on (b)(6) 2020 the primary fusion procedure (l2-5) was performed.On an unknown date the patient fell over, and the screws at l5 broke off.The surgeon commented that the event would not adversely affect the patient¿s health.So any medical intervention is not planned.This report is for one (1) viper system x-tab cortical fix polyaxial screw 5.5 7.0mm x 45mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 45MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12589130
• Report Number: 1526439-2021-02121
• Device Sequence Number: 11877250
• Product Code: KWP
• UDI-Device Identifier: 10705034465791
• UDI-Public: (01)10705034465791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: 186770145
• Device Catalogue Number: 186770145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 10/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORTICAL FIX X-TAB 7X45MM TI