MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CORTICAL FIX X-TAB 7X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770145
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional 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: a review of the receiving inspection (ri) for cortical fix x-tab 7x45mm ti was conducted identifying that lot number tbtsx was released in a single batch.Batch1: lot qty of (b)(4) units were released on 22 feb 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 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) cortical fix x-tab 7x45mm ti.This report is 6 of 7 for (b)(4).

• Brand Name: CORTICAL FIX X-TAB 7X45MM 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: 12320331
• Report Number: 1526439-2021-01690
• Device Sequence Number: 4173601
• Product Code: NKB
• UDI-Device Identifier: 10705034465791
• UDI-Public: 10705034465791
• 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
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 186770145
• Device Catalogue Number: 186770145
• Device Lot Number: TBTSX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 TI CORT FIX 8X45MM; 5.5 TI CORT FIX 8X45MM; CORTICAL FIX X-TAB 7X40MM TI; CORTICAL FIX X-TAB 7X45MM TI; CORTICAL FIX X-TAB 7X45MM TI; VIPER TI SAI POLY 9X80MM
• Outcome Attributed to Adverse Event: Required Intervention