MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 5.0X25; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 199725525S

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

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.D2b: additional device product codes: kwp, kwq, mnh, osh, mni d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, a spinal fusion for scoliosis was performed.Regarding the screw inserted into t9, the final tightening of the outer set screw of a correction key could be done, but the final tightening of the inner set screw of the correction key could not be done.Therefore, the surgeon removed the correction key and attempted to set a new correction key, but he couldn¿t.The threaded part that combines with a set screw inside the screw head seems to have been broken.As a result, a unitized set screw could not be placed, and the procedure was completed without placing either the correction key or the unitized set screw.The surgeon was also of the opinion that as a result of the cross-threading occurred, the threaded part that combines with the set screw inside the screw head broke eventually.Regarding the screw inserted into t10, the same phenomenon occurred.The final tightening of the outer set screw of a correction key could be done, but the final tightening of the inner set screw of the correction key could not be done.Therefore, the surgeon removed the correction key and attempted to set a new correction key, but he couldn¿t.However, a unitized set screw could be set, the surgeon set the unitized screw and completed the procedure.The surgery was completed successfully within 30 minutes delay.This report involves one 5.5 exp verse can scr 5.0x25.This is report 1 of 2 for (b)(4).

• Brand Name: 5.5 EXP VERSE CAN SCR 5.0X25
• 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 ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17700238
• MDR Text Key: 322859155
• Report Number: 1526439-2023-01617
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440460
• UDI-Public: (01)10705034440460
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142185
• 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: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725525S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• 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: 5.5 EXP VERSE CAN SCR 6.0X30