MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM VERSE; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 199723650

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned for evaluation.

Event Description

L4/s1 posterior stabilization.Patient presented for routine 3 month post op.Follow up, complaining of back pain.Upon investigation, the imaging revealed that the construct rods had migrated cranially, and are completely out of the s1 screws.This is evident when comparing the construct to the image taken immediately post op.

Manufacturer Narrative

Visual examination of the returned device revealed superficial markings and slightly stripped drive feature.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 cannot be identified from the returned devices.No other patient information or factors that may affect the performance of the components were provided.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 VERSE
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: 6988122
• MDR Text Key: 90586891
• Report Number: 1526439-2017-10932
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034403076
• UDI-Public: (01)10705034403076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 199723650
• Device Catalogue Number: 199723650
• Device Lot Number: AVDC6M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other