MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 179771555

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 11/06/2023

Event Type  Injury  

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.H10 additional narrative: d2b: additional device product codes: mnh, osh, kwq, kwp, mni.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 Description

It was reported that on (b)(6) 2023, the rod became disconnected from the connector.Due to postoperative loosening of the set screw, revision surgery was performed on (b)(6) 2023.The patient experienced pain as a result of the event.This report involves one expedium spine system side loading open/open top notch connector 5.5 x 5.5mm.This is report 1 of 3 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 X 5.5MM
• 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 (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18245775
• MDR Text Key: 329477346
• Report Number: 1526439-2023-02495
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 179771555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS,; UNKNOWN RODS.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 82 KG