MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problems Device Slipped (1584); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2024

Event Type  Injury  

Event Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2024 an unknown surgery for th12, l1 compression fracture was performed.During the surgery, the screw was inserted by prime method.A short screw (5 x 30 mm) was inserted into the l1 vertebra.After insertion of the screw, the rod was placed.Final fastening and tab cutting were performed after confirming that the rod was coming out on the craniocaudal side in the image.After the wound was closed, an x-ray was taken and upon reviewing the images, it was noticed that the screw in question on the left side of l1 broke.The surgery was started again and only the left side was deployed and the broken screw was removed.The surgeon reinserted 5 x 45mm screw and fasten rod.After checking the image, the surgery was completed successfully with over 30 minutes surgical delay.No further information is available.This report is for an unk rod.This is report 2 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.H10 additional narrative: g4 ¿ 510k: this report is for an unknown rod.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes 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.

Event Description

There was no adverse patient impact, their status is stable.No removal or revision procedure has been performed.

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.Additional information added to event description.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK RODS
• 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: 18801638
• MDR Text Key: 336509636
• Report Number: 1526439-2024-00963
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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: VIPER PRIME CFX XTAB 5X30MM TI.
• Patient Outcome(s): Required Intervention