MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 8X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186731845
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
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, mnh, mni, osh.Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported that patient underwent a posterior lumbar spinal fusion (l2-sai) treating degenerative disease on (b)(6) 2019.The surgeon tried to remove a formerly implanted cfs7.0-45mm screw on l3 left and implant a cfs8.0-45mm screw instead.Because the new screw seemed tight (sticking out approximately 2mm than expected), the surgeon tried to remove it.Then, the following events occurred in sequence: the tip of the driver shaft broke.As the surgeon tried to remove the screw by fixing a rod and a setscrew, the screw head of the cortical fix screw came off.The rod holder broke.The surgeon decided to leave the fragmented core of the cortical fix screw in the patient¿s body due to the limited surgical time.Since l3 left was not fixed, the screw stabilization has decreased a little.The patient is recovering.Concomitant devices: setscrews (part: unknown, lot: unknown, quantity: unknown), rod (part: unknown, lot: unknown, quantity: unknown).This report is for a 5.5 titanium (ti) cortex fix screw 8x45mm.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: 5.5 TI CORT FIX 8X45MM
• 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: 9355442
• Report Number: 1526439-2019-52470
• Device Sequence Number: 1763010
• Product Code: NKB
• UDI-Device Identifier: 10705034352190
• UDI-Public: (01)10705034352190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186731845
• Device Catalogue Number: 186731845
• Device Lot Number: 206878
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Patient Age: 74 YR