MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 7.0 X 60; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	199721760
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional 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.D2: additional procodes: kwp, kwq, mnh, mni, osh.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: a manufacturing record evaluation was performed for the finished device.Product code: 199721760.Lot: 355602.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: october 11, 2022.Manufacturing site: jabil le locle.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.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 or Problem Description
Device report from colombia reports an event as follows: it was reported that during a procedure on (b)(6) 2023, the supplied ileosacral screws were not compatible with expedium verse.Patient had a fracture and required placing a screw in l5 and a screw to the sacrum.When the system was placed, the screw recess and the locking bushings were different.This was reported to the specialist and, as the patient was already in the intervention, a 7.0 x 60 screw (the longest of expedium verse) was placed, when the appropriate measure was 7.0 x 90.It was fixed in l5 with a 6.0 x 40 screw and the corresponding bar was adjusted.This report is for a 5.5 exp verse screw 7.0 x 60.This is report 1 of 1 for (b)(4).

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 60
• Common Device Name: 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: 16896934
• Report Number: 1526439-2023-00813
• Device Sequence Number: 6312146
• Product Code: NKB
• UDI-Device Identifier: 10705034442075
• UDI-Public: (01)10705034442075
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199721760
• Device Catalogue Number: 199721760
• Device Lot Number: 355602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS
• Patient Sex: Unknown