MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CORTICAL FIX X-TAB 6X40MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186760140

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Tissue Damage (2104); Not Applicable (3189)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2017, the tlif surgery was performed by using the expedium viper ii system.The fixed area was l5 - s1.After the surgery, it was found under the x-ray that part of the broken tab of cortical fix x-tab (186760140) at s1 had been left in the patient¿s body.It is not clear when the hospital noticed this event.The surgeon comments as follows.No adverse consequence to the patient has been confirmed after the surgery the patient is postoperatively in a good condition because his/her preoperative paralysis has been improved and the pain as well has completely gone away.No operation to remove the part of the broken tab is required.

• Brand Name: CORTICAL FIX X-TAB 6X40MM TI
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7682410
• MDR Text Key: 113798597
• Report Number: 1526439-2018-50650
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034465456
• UDI-Public: (01)10705034465456
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 186760140
• Device Catalogue Number: 186760140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention