MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 189401406

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was an original unknown surgery occurred on (b)(6), 2020.Post-operatively on an unknown date, adjacent segment disease (asd) occurred.A revision surgery occurred to extend fixation and remove hardware on (b)(6), 2023.The sfx cross-link was removed.Set screw and rod were removed.Of the screws in l3-5, only l3 and l4 screws were removed.(bone fusion was completed) l5 screw were preserved.S additional screw of 7.0-45mm diameter was inserted.L5-s tlif was performed.(cage was other company¿s product.) sfx cross-link was placed, and the final tightening was done.This report is for one expedium sfx cross connector system connector a6 5.5 x 49-66mm for (b)(6).(b)(6) are linked.Additional impacted products are captured for the event.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B3: unknown when asd occurred d9: complainant part is not expected to be returned for manufacturer review/investigation.D10 concomitant therapy date (b)(6) 2020.E1: initial reporter is j&j company representative h4: device history a review of the receiving inspection (ri) for sfx,5.5,ti, med, size a6 was conducted identifying that lot number om10465 was released in one batch.¿ batch 1: lot qty of 44 units were released on 05 sep 2019 with no discrepancies.Supplier: medos int.Spine 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.H6: 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.

• Brand Name: EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18597905
• MDR Text Key: 334037659
• Report Number: 1526439-2024-00731
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034168135
• UDI-Public: (01)10705034168135
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 189401406
• Device Lot Number: OM10465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X50MM; 5.5 TI CORT FIX 7X50MM; CONCORDE PROTI, 5DG,9X10X27 MM; SFX,5.5,TI, MED, SIZE A6; VIPER2 LORDOTIC ROD-85MM; VIPER2 LORDOTIC ROD-85MM
• Patient Outcome(s): Required Intervention