MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR M/L SCREW 4.0 DIA X 24; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 188319424

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

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 spine fusion surgery was performed on (b)(6) 2018 to fix c7 right.During the surgery, after the surgeon implanted 4th screw to the patient¿s spine, it was reported that the surgeon recognized that there were broken fragment of the screw adhered to the screw driver.The surgery was completed by replacing the suspected screw to new screw.The surgeon confirmed that there was no broken fragment remained in the patient¿s body under x-ray.No further information was provided by the hospital.

Manufacturer Narrative

(b)(4).Visual examination found that the polyaxial¿s tulip head inner cap had become disassembled from its intended position.No damage was present on the polyaxial screw shank.Swage markings were present indicative of the inner cap being properly placed in its intended position within the tulip head.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¿s inner cap becoming disassembled from its intended position cannot be positively determined.However, it is suggested that unanticipated high amount of forces was placed on the tulip head resulting in the inner cap becoming disassembled from its intended position.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: MNTR M/L SCREW 4.0 DIA X 24
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8111169
• MDR Text Key: 129071307
• Report Number: 1526439-2018-51095
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034157894
• UDI-Public: (01)10705034157894
• Combination Product (y/n): N
• PMA/PMN Number: K041203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 188319424
• Device Catalogue Number: 188319424
• Device Lot Number: APDB41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1