MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM 5.5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number UNK - MONO/POLYAXIAL SCREWS: E

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that the patient underwent a surgery on (b)(6) 2024.The surgeon placed screws and upon rod reduction wanted to backup two screws to help with reduction.Two screws had failure within the tulip and needed to be removed and replaced.The collar within the tulip came apart and made rod reduction impossible.No other screws failed when adjusting.No further information is available.This report involves one unk - mono/polyaxial screws: expedium 5.5.This is report 1 of 2 for (b)(4).

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: d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown mono/polyaxial screws: expedium 5.5 /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.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: UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM 5.5
• 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: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18939711
• MDR Text Key: 338112798
• Report Number: 1526439-2024-01084
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - MONO/POLYAXIAL SCREWS: E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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: UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM 5.5; UNKNOWN RODS