MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CORTICAL FIX X-TAB 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186760145
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the plif surgery was performed on (b)(6) 2018.During the surgery, the surgeon could not cut the tab properly thus the surgeon could not attach it to the driver tip.The surgery was finished without any other problem although it was not reported how the surgery was completed.There was less than 30min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Udi: ((b)(4).The returned screw features minimal signs of use.However, the top third of the first thread on one side of the tulip head have been torn off.This has left this side of the tulip head with a section of thread protruding from the side of the screw.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.The root cause of the damage to the thread of the poly screw cannot be determined from the sample and the information provided.A potential root cause may be inadvertently cross threading a set screw during insertion into the extended tabs of this poly screw.This would place stress on the threads of the tulip head, potentially resulting in them becoming damaged or 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.

• Brand Name: CORTICAL FIX X-TAB 6X45MM 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: 8268294
• Report Number: 1526439-2019-51265
• Device Sequence Number: 2370303
• Product Code: NKB
• UDI-Device Identifier: 10705034465463
• UDI-Public: (01)10705034465463
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 186760145
• Device Catalogue Number: 186760145
• Device Lot Number: TBTCY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other