MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE MIS CANNULATED CORTICAL FIX X-TAB 7X50MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186770150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
On (b)(6) 2017, surgery for spinal canal stenosis was performed using the x-tab system.The fixed area was l3 ¿ l4.During the surgery, the surgeon faced the following difficulties and completed the surgery successfully.The patient¿s bones were so hardened and the pedicle areas as well.The surgeon managed to insert x-tab (part#: 186770150, lot#: unk) at l3 and l4 using a t-handle, however, the length of each tab was different.To adjust the length of each tab, the surgeon tried to insert it again by using driver (part# & lot#: unk) and wrench for final tightening (part# & lot#: unk), and then one tab of x-tab got broken due to hardened bones.The surgeon successfully inserted it and adjust its length by using the viper extender and vbd instrument set.The x-tab was used because tab was broken properly.No broken parts were found left in the body, and the surgery was successfully completed with a 10-minute delay.There was no adverse consequence to the patient.

• Brand Name: MIS CANNULATED CORTICAL FIX X-TAB 7X50MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6831549
• Report Number: 1526439-2017-10724
• Device Sequence Number: 44733
• Product Code: NKB
• UDI-Device Identifier: 10705034465807
• UDI-Public: (01)10705034465807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2017

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: Physician
• Device Model Number: 186770150
• Device Catalogue Number: 186770150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/30/2017
• Patient Sequence Number: 1