MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X16; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	1020-35-116
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: kwp 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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) 2021, during posterior spinal fusion surgery there were multiple issues while using symphony.It was noticed that the screw head chip when a set screw was apparently cross threaded while using the reduction gun.It was unknown how it occurred.Also, there were two set screw drivers that had tips sheared off while inserting set screws.Fragments were generated and easily removed.There was a surgical delay of ten (10) minutes.There were no patient consequences.The procedure was successfully completed.Concomitant device reported: unknown reduction gun (part# unknown, lot# unknown, quantity unknown) this complaint involves four (4) devices.This report is for (1) 4.0 ply scrw 3.5x16 this report is 1 of 4 for (b)(4).

• Brand Name: 4.0 PLY SCRW 3.5X16
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12203191
• Report Number: 1526439-2021-01441
• Device Sequence Number: 5061224
• Product Code: NKG
• UDI-Device Identifier: 10705034508702
• UDI-Public: 10705034508702
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K181949
• 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): 06/22/2021

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: 1020-35-116
• Device Catalogue Number: 102035116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1