MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI UNI SCREW 7MM X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179788745
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: kwp;mnh;mni;osh.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is company sales consultant.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 or Problem Description
It was reported that on an unknown date, while the surgeon was reducing the rod and noticed that the set screw would not seat into the head of the screw.Upon further examination, it was noted that the screw head inner saddle had somehow risen up into the tulip of the screw which was preventing the rod from being reduced.This may have happened when the surgeon was rotating the heads of the screws with a cobb elevator instead of the head turner.Procedure and patient outcome are unknown.Concomitant device reported: set screws (part#: unknown, lot#: unknown, quantity: 1), rod (part#: unknown, lot#: unknown, quantity: 1).This is report 1 of 1 for (b)(4).

• Brand Name: EXP TI UNI SCREW 7MM X 45MM
• 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: 9575763
• Report Number: 1526439-2020-00343
• Device Sequence Number: 2901502
• Product Code: NKB
• UDI-Device Identifier: 10705034081571
• UDI-Public: (01)10705034081571
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 179788745
• Device Catalogue Number: 179788745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/10/2020
• Patient Sequence Number: 1