MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 6.35 X 4.35 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179988435
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: osh, kwq, mnh, mni, kwp.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(4).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.Photo investigation: the device was not returned.A photo-investigation was performed on the images located in pc attachment ¿(b)(4)".Upon inspecting the images provided, it was observed the threaded portion of the screw was broken in two pieces.However, the root cause of the breakage cannot be determined based on the available image.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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
It was reported that on (b)(6) 2021, the screw was broken, patient had marfan's syndrome.The patient need's a revision surgery.This report is for one (1) expedium spine system uniplanar screw 6.35 x 4.35 x 35mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 6.35 X 4.35 X 35MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12586850
• Report Number: 1526439-2021-02119
• Device Sequence Number: 11739340
• Product Code: NKB
• UDI-Device Identifier: 10705034092959
• UDI-Public: (01)10705034092959
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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: 179988435
• Device Catalogue Number: 179988435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR