MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number 179702000

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, that three of our expedium 5.5 set screws were loose at the bottom of the construct that our surgeon, doctor was revising.The procedure was a t10-iliac fusio.Doctor replaced the rods and set screws with new rods and set screws of our expedium 5.5 system.The patient was scheduled for a revision case 3 weeks following their initial procedure where doctor inserted new iliac screws, rods, and set screws of our expedium 5.5 system.There was no surgical delay.The procedure completed successfully.This complaint involves three (3) devices.This report is for one (1) single-inner setscrew.This is report 2 of 3 for complaint: (b)(4).

Manufacturer Narrative

Product complaint#: (b)(4).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.H10 additional narrative: d2b.Additional pro-codes: kwp, mnh, kwq, mni, nkb.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.

• Brand Name: SINGLE-INNER SETSCREW
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• 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: 17092519
• MDR Text Key: 316848828
• Report Number: 1526439-2023-01038
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• 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
• 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: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702000
• Device Catalogue Number: 179702000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• 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: SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNK - RODS
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male