MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER UNI SCREW 5X35MM TI; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	186720535
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2022, while doing the final lock, after the maneuver override, the surgeon found that the rod was not tightly blocked into the uniplanar screw heads.This was in comparison with the upper and lower poly axial screws with the fixation to the rod was very solid.With the uniplanar screws, one could clearly see an unexpected medio-lateral movement/degree of freedom despite an ad-hoc tightening with the torque handle.The surgery was successfully completed without any surgical delay.No patient consequences reported.This report is for one (1) viper uni screw 5x35mm ti.This is report 3 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional device product codes: nkb;kwq;mnh;mni;osh.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.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.

• Brand Name: VIPER UNI SCREW 5X35MM TI
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13517753
• Report Number: 1526439-2022-00210
• Device Sequence Number: 4473814
• Product Code: KWP
• UDI-Device Identifier: 10705034125619
• UDI-Public: (01)10705034125619
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 186720535
• Device Catalogue Number: 186720535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS; VIPER UNI SCREW 5X35MM TI; VIPER UNI SCREW 5X35MM TI
• Patient Sex: Unknown