MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CORTICAL FIX X-TAB 7X40MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770140
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 plif (posterior lumbar interbody fusion) for l2-5 treating lscs (lumbar spinal canal stenosis) on (b)(6) 2019.When compression was applied to the screw, it moved laterally, and the compression failed.Replacing a setscrew did not correct the issue.Finally, the surgeon completed the procedure with a replacing screw with less than thirty (30) minutes surgical delay.It was postoperatively known that another surgeon was not able to apply a non-j&j probe to the targeted lesion prior to the screw¿s insertion.When the probe happened to be applied laterally off the targeted area, the pedicle bone broke/fractured.They concluded that the compression through the screw failed due to such a probe application.The surgeon postoperatively confirmed that the viper compressor could apply compression appropriately.This report is for a titanium (ti) mis cannulated cortical fix x-tab 7x40mm.This is report 1 of 2 for (b)(4).

• Brand Name: CORTICAL FIX X-TAB 7X40MM TI
• 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: 9545007
• Report Number: 1526439-2020-00112
• Device Sequence Number: 2275778
• Product Code: NKB
• UDI-Device Identifier: 10705034465784
• UDI-Public: (01)10705034465784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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: 186770140
• Device Catalogue Number: 186770140
• Device Lot Number: TBTTE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 01/03/2020
• Patient Sequence Number: 1