MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 5.0X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	199723545S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procodes: kwp, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The device history record (dhr) of product code 199723545s, lot 215931 was reviewed and no non-conformances were observed during the manufacturing process.The product was released on october 3, 2018.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the received image(s).The image(s) was reviewed, and the complaint condition could be confirmed since the distal tip of the screw had broken off.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.(b)(4).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 (b)(6) reports an event as follows: it was reported that in a post-surgery mri, that the expedium verse screw was broken in the tip.The tip is located inside the vertebral body, currently without problems for the patient.The patient was initially treated for adolescent idiopathic scoliosis - deformity.There is no plan for revision surgery.This report is for a 5.5 expedium verse fenestrated screw.This is report 1 of 1 for (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 5.0X45
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11725486
• Report Number: 1526439-2021-00790
• Device Sequence Number: 3894724
• Product Code: NKB
• UDI-Device Identifier: 10705034443324
• UDI-Public: (01)10705034443324
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199723545S
• Device Catalogue Number: 199723545S
• Device Lot Number: 215931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention