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

Model Number	186770040
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Spinal Column Injury (2081); No Code Available (3191)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Visual examination at the macroscopic level found that the polyaxial screw shank had fractured.The second half of the shaft was not provided as it remained implanted in the patient.A fracture analysis was conducted on the returned device.It was noted that the fracture analysis exhibits two surface morphologies, a smooth region and a grainy/rough region with progression lines which are indicative of fatigue failure.In addition, it was noted that the initial thread on the polyaxial¿s tulip head had become torn.Noted damage suggests that the tulip head¿s thread was subjected to unanticipated forces, resulting in the thread becoming torn.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the polyaxial screw¿s fractured shank and torn tulip head¿s thread cannot be positively determined.However, the fracture analysis exhibits two surface morphologies, a smooth region and a grainy/rough region with progression lines which are indicative of fatigue failure.In addition, it is suggested that the tulip head¿s thread was subjected to unanticipated forces, resulting in the thread becoming torn.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.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 the primary surgery was performed via mis-tlif to fix l4/5 on unknown date.The extension surgery to extend to l4-sai was performed on (b)(6) 2018, and was planned to keep using l4/5 screws.It was reported that the surgeon recognized that the l5 left screw was broken during the extension surgery.The surgeon decided to keep the broken screw into the patient¿s l5 because the surgeon judged that the broken screw was hard to remove.The surgery was completed by using another screw to implant the extension rod.After the surgery, the surgeon checked the x-ray (before surgery x-ray) found that the l5 left screw was already broken before the surgery.There was no surgical delay.No further information was provided by the hospital.

• Brand Name: MIS CANNULATED X-TAB 7X40MM TI
• 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: 8126288
• Report Number: 1526439-2018-51118
• Device Sequence Number: 14044263
• Product Code: NKB
• UDI-Device Identifier: 10705034129662
• UDI-Public: (01)10705034129662
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

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: 186770040
• Device Catalogue Number: 186770040
• Device Lot Number: ARKBK8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1