MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X20; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	1020-35-120
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Initial reporter is synthes sales representative.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 on an unknown date, during posterior spinal fusion c1-c2 procedure, the surgeon described having difficulty starting the screw despite having tapped with a 3.5 diameter tap.The tip of the screw was not engaging and only after tapping with a 4.0 diameter tap, the surgeon was able to insert the 3.5mm diameter screw to engage with the bone.Procedure was completed successfully.This report is for one (1) 4.0 ply scrw 3.5x20.This is report 1 of 3 for (b)(4).

• Brand Name: 4.0 PLY SCRW 3.5X20
• 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 ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14102706
• Report Number: 1526439-2022-00564
• Device Sequence Number: 6427903
• Product Code: KWP
• UDI-Device Identifier: 10705034508726
• UDI-Public: (01)10705034508726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: 1020-35-120
• Device Catalogue Number: 102035120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/13/2022
• 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: 4.0 PLY SCRW 3.5X16; 4.0 PLY SCRW 3.5X30
• Patient Sex: Unknown