MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 60; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199721660
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional procodes: kwp, kwq, mni, osh complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a depuy employee.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.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 colombia reports an event as follows: it was reported that during a procedure on (b)(6) 2019, at the time of placing the double-pass bushing to the screw, it looked 6.0x60mm and it did not reach a stop.When trying to give it the final torque, it was not possible.Another double-pass bushing was passed, and it passed the same as the first one and it is evidenced as threads of titanium that came out when placing the bushing.It was also tried with a simple bushing and the same thing happened; the screw fins are broken, and the bushing was tried to be placed but was not possible.It was decided to change the screw for another one since several attempts were made with no success.The screw was changed and one of the previously used bushings was used.This report is for an expedium® verse spine system screw.This is report 1 of 2 for (b)(4).

• Brand Name: 5.5 EXP VERSE SCREW 6.0 X 60
• 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: 9309811
• Report Number: 1526439-2019-52389
• Device Sequence Number: 468268
• Product Code: NKB
• UDI-Device Identifier: 10705034442242
• UDI-Public: (01)10705034442242
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 199721660
• Device Catalogue Number: 199721660
• Device Lot Number: 129672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/12/2019
• Patient Sequence Number: 1