MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 4; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 199723640

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Awaiting sample: a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not yet returned for evaluation.

Event Description

Grade 4 spondylolithesis correction l5/s1.A spondylolithesis correction that was performed on the (b)(6) 2017 was revised for construct failure.The patient had a verse screw 6 x 40 mm fracture through the vertebral body of s1 on the left side.The right side l5 screw had also disconnected with the 35 mm viper rod, set screw was still in the screw head.On removal of the construct the surgeon noticed that the l5 left sided set screw appeared to be loose.The surgeon removed all screws, rods, set screws (6 x 40 mm at s1 and 6 x 35 mm l5) and medtronic r90 implants (plif cage).Then replaced the screws at l5 with x 27 x 35 mm screws and x 17 x 40 mm at s1 left side and x17 x 35 at s1 right side.He also place sai (sacral alar iliac screws) 8 x 80 mm screws in the pelvis.He then replaced the rods (cocr) and reduced l5 back into position and replaced medtronic r90 interbody cages, compressed at l5/s1 and final tightened.The revision surgery was uneventful.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.Visual examination found no damage or defects beyond signs of use.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.The root cause of one of the polyaxial screws migrating postoperatively could not be determined by the samples or information provided.The samples do not provide enough evidence to confirm the reported failure.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 SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 4
• 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: 6824812
• MDR Text Key: 83814582
• Report Number: 1526439-2017-10708
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034403090
• UDI-Public: (01)10705034403090
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/09/2017

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: 199723640
• Device Catalogue Number: 199723640
• Device Lot Number: 101761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 14 YR