MAUDE Adverse Event Report: DEPUY SYNTHES SPINE BREMER 3D HALO CROWN; COMPONENT, TRACTION, INVASIVE

Model Number 292301001

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6), surgery for cervical hangman's fracture was performed using the halo system.Ten days after the surgery, the surgeon confirmed that the screws, which were fixed on the crown and vest, were broken and its fixation force was lost.On (b)(6), the surgeon performed the revision surgery where the halo in use was removed and a new device was fixed.The revision surgery was successfully completed with a 30-minute delay.

Manufacturer Narrative

Visual examination of the returned device found one of the screws fixed to the crown was broken.A trend analysis was performed.No emerging trends were found requiring further actions.A definitive root cause cannot be positively determined.However, based on the visual evaluation of the returned sample, the possible cause of the defect is the screw been subjected unanticipated torsional forces during tightening process.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: BREMER 3D HALO CROWN
• Type of Device: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7005866
• MDR Text Key: 91213716
• Report Number: 1526439-2017-10939
• Device Sequence Number: 1
• Product Code: JEC
• UDI-Device Identifier: 10705034341880
• UDI-Public: (01)10705034341880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

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
• Device Operator: Physician
• Device Model Number: 292301001
• Device Catalogue Number: 292301001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention