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

Model Number 186731845

Device Problem Device Slipped (1584)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review /investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part # 186731845, lot # 225686, supplier: (b)(4).No ncr's were generated during production.Batch # 1 qty - (b)(4) release to warehouse date: 27 dec 2018.Batch # 2 qty - (b)(4) release to warehouse date: 28 dec 2018.Batch #3 qty - (b)(4) release to warehouse date: 28 dec 2018.Batch #4 qty - (b)(4) release to warehouse date: 31 dec 2018.Batch#5 qty - (b)(4) release to warehouse date: 02 jan 2019.Batch#6 qty - (b)(4) release to warehouse date: 15 jan 2019.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for revision procedure (l3-s) due to suffered from asd at l3.When the revision procedure (l3-s) was performed, screw loosening was revealed, which was replaced with a new screw.It was unknown if the revision surgery completed successfully.The patient outcome was unknown.The primary olif and tlif (l3-sai) were performed on (b)(6) 2019.This complaint involves seven (7) devices.This report is for (1)5.5 ti cort fix 8x45mm.This report is 3 of 7 for (b)(4).

• Brand Name: 5.5 TI CORT FIX 8X45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12319617
• MDR Text Key: 266465519
• Report Number: 1526439-2021-01683
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034352190
• UDI-Public: 10705034352190
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731845
• Device Catalogue Number: 186731845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 8X45MM; CORTICAL FIX X-TAB 7X40MM TI; CORTICAL FIX X-TAB 7X45MM TI; CORTICAL FIX X-TAB 7X45MM TI; CORTICAL FIX X-TAB 7X45MM TI; VIPER TI SAI POLY 9X80MM
• Patient Outcome(s): Required Intervention