MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR H/H X-CONN OUTER NUT; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	188341100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the posterior cervical fusion (c1) with the outer nut in question.Procedure was completed successfully without any surgical delay.On (b)(6) 2021, it was confirmed by x-ray, that the outer nut came off at follow-up just before discharge.According to the video taken during the surgery, the outer nut was properly tightened with the torque driver for the final tightening.After the surgery, the patient has been undergoing rehabilitation.This report is for one (1) mntr h/h x-conn outer nut.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Additional product code: mni, nkg.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: MNTR H/H X-CONN OUTER NUT
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12869016
• Report Number: 1526439-2021-02473
• Device Sequence Number: 6025526
• Product Code: KWP
• UDI-Device Identifier: 10705034158662
• UDI-Public: (01)10705034158662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 10/28/2021

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: 188341100
• Device Catalogue Number: 188341100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown