MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 5X25MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186731525

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the posterior thoracic fusion surgery was performed on (b)(6) 2019 due to nerve compression due to malignant spine metastasis.During the surgery, after the surgeon implanted the screw into patient¿s thoracic spine, when the surgeon tried to implant the rod (p/n and lot# were unknown), it was reported that the surgeon recognized that the collet part at the screw head was twisted and broken.The implanted screw was revised to alternative screw, and completed the surgery.There was no information of surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was not returned for evaluation.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.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.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, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 TI CORT FIX 5X25MM
• Type of Device: 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: 8550028
• MDR Text Key: 144569727
• Report Number: 1526439-2019-51560
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034351599
• UDI-Public: (01)10705034351599
• Combination Product (y/n): N
• PMA/PMN Number: K110216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731525
• Device Catalogue Number: 186731525
• Device Lot Number: ATCCBL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1