MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 7X40MM S; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770440S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: kwp and kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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) 2021, the patient underwent for primary transforaminal interbody fusion l5/s1 surgery.During the surgery, when attempting to lock off set screws, the rod slipped out of the tulip and set screw was spinning in head of screw due to cross-threading.After several attempts, the surgeon was able to loosen the set screw, remove it and re-introduce x2 new set screws.The procedure was then safely completed.The surgery was completed with twenty-five (25) minutes surgical delay.There were no patient consequences reported.This report is for (1) viper prime cfx fen x-tab polyaxial screw 5.5 7 x 40mm.This report is 3 of 3 (b)(4).

• Brand Name: VIPER PRIME CFXFN XTB 7X40MM S
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11870865
• Report Number: 1526439-2021-01031
• Device Sequence Number: 3201998
• Product Code: NKB
• UDI-Device Identifier: 10705034530246
• UDI-Public: (01)10705034530246
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2021

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: 186770440S
• Device Catalogue Number: 186770440S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2021
• Initial Report FDA Received Date: 05/24/2021
• Patient Sequence Number: 1