MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 LORDOTIC ROD-40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186788040S
Medical Device Problem Code	Device-Device Incompatibility (2919)
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
Product complaint # (b)(4).Without a lot number, the device history records review could not be completed as no product was received.The device was received, the investigation is in progress, 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
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.The surgery was completed with 25 minutes delay.There were no patient consequences are reported.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity unknown).This complaint involves three (3) devices.This report is for (1) viper2 lordotic rod-40mm.This report is 1 of 2 (b)(4).
Event or Problem Description
This report is 1 of 4 for (b)(4).

• Brand Name: VIPER2 LORDOTIC ROD-40MM
• 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: 11865727
• Report Number: 1526439-2021-01029
• Device Sequence Number: 3193927
• Product Code: NKB
• UDI-Device Identifier: 10705034238210
• UDI-Public: 10705034238210
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131802
• 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,Followup
• 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: 186788040S
• Device Catalogue Number: 186788040S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS SINGLE INNER SETSCW; UNKNOWN SCREWDRIVERS; VIPER PRIME CFXFN XTB 7X40MM S