MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS CANNULATED X-TAB 7X40MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770040
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Investigation summary.Investigation flow: damage.Visual inspection: the mis cannulated x-tab 7x40mm ti (p/n: 186770040, lot number: tbdbe) was received at us cq.Visual inspection of the complaint device showed the shaft of the screw had broken off just below the ball head.No material deficiencies were observed.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the screw shaft had broken off below the ball head.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot a review of the receiving inspection (ri) for mis cannulated x-tab 7x40mm ti was conducted identifying that lot number tbdbe was released in a single batch.- batch1: lot was released on nov 1, 2012 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 that on (b)(6) 2020, the patient underwent for an xlif (extreme lateral interbody fusion) at l4/5.When surgeon removing the screws at s., the screwhead came off.Surgeon left the shaft in the patient.All fragments were left in the patient.The surgery was completed with 30 minutes delay.The patient is not scheduled to undergo another procedure.The patient outcome was unknown.This report is for one (1) mis cannulated x-tab 7x40mm ti.This report is 2 of 2 for (b)(4).

• Brand Name: MIS CANNULATED X-TAB 7X40MM TI
• 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: 11238477
• Report Number: 1526439-2021-00203
• Device Sequence Number: 19903388
• Product Code: NKB
• UDI-Device Identifier: 10705034129662
• UDI-Public: 10705034129662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• 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): 01/06/2021

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: 186770040
• Device Catalogue Number: 186770040
• Device Lot Number: TBDBE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1