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

Model Number 186760045

Device Problem Separation Failure (2547)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Post-op films the day after the case, revealed that the x-tabs on the left side of the construct did not fully break off the screw.They broke off just above the threads.The patient was taken back into surgery the next day to remove the remainder of the x-tab.

Manufacturer Narrative

Visual examination of the broken tab revealed the it was broken above the intended breaking point.A review of the device history record could not be performed as the lot number was not provided.A trend analysis was conducted.No emerging trends were found requiring further actions.The investigation could not verify or identify any evidence of product contribution to the reported event.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: VIPER
• 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: 6918196
• MDR Text Key: 88457126
• Report Number: 1526439-2017-10805
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034129204
• UDI-Public: (01)10705034129204
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 186760045
• Device Catalogue Number: 186760045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR