MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 480 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179762480

Device Problem Break (1069)

Patient Problem Spinal Column Injury (2081)

Event Date 01/01/2018

Event Type  Injury  

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

Rod fracture after fusion surgery with exepdium system.Patient consequence?: yes.Patient consequence description: revision surgery.Action taken for procedure: revision surgery.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

Manufacturer Narrative

(b)(4).Visual examination found that the rod had fractured into two separate pieces of unequal size.Device was then sent for fracture analysis which suggests that the rod failed under a fatigue fracture.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 rod fracturing cannot be positively determined.However, the fracture analysis report suggests that the rod failed under a fatigue fracture.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: ROD, 480 MM
• 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
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7751900
• MDR Text Key: 116071971
• Report Number: 1526439-2018-50735
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077437
• UDI-Public: (01)10705034077437
• Combination Product (y/n): N
• PMA/PMN Number: K033901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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
• Device Operator: Health Professional
• Device Model Number: 179762480
• Device Catalogue Number: 179762480
• Device Lot Number: BDJ373L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention