MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179712740

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Injury (2348); Device Embedded In Tissue or Plaque (3165)

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

Revision of s1 left.For broken screw.When the surgeon went to remove the screw, the tip broke part of the shank is still in patient could not retrieve, placed a new screw in s2.Surgeon thinks original surgery was done in 2014.

Manufacturer Narrative

Visual examination at the macroscopic level revealed that the polyaxial screw fractured along the screw shank.The distal portion of the screw shank was not returned for analysis.Device was sent for fracture analysis which suggests fatigue first propagated along the progression line across the smooth surface region, then full failure / breakage occurred in the rough region at the termination site.No material defects or other abnormalities have been identified in the fracture analysis report.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.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the polyaxial screw fracturing cannot be positively determined.However, the fracture analysis report identified that the failure was indicative of fatigue.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: EXPEDIUM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7009075
• MDR Text Key: 91325579
• Report Number: 1526439-2017-10955
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034067896
• UDI-Public: (01)10705034067896
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

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: 179712740
• Device Catalogue Number: 179712740
• Device Lot Number: AJFBRV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention