MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199723740S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was expected to undergo a revision surgery for removing a screw and extending the fusion up to the ilium.The patient had posterior thoracolumbar fusion) at th9-l3 was performed on (b)(6) 2021 for treating centrum fracture due to osteoporosis.The cement was applied at l3.The patient¿s l3 centrum was found fractured where the cement was applied.The patient was in pain.No further information is available.This complaint involves one (1) device.This report is for (1) 5.5 exp verse fen scr 7.0x40.This report is 1 of 1 for (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X40
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12178014
• Report Number: 1526439-2021-01418
• Device Sequence Number: 19240409
• Product Code: NKB
• UDI-Device Identifier: 10705034444512
• UDI-Public: 10705034444512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 199723740S
• Device Catalogue Number: 199723740S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention