MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY

Model Number 283913000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Without a valid lot number the device history records review could not be completed.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2021, during spinal fusion surgery the surgeon was revising an l1 to s1 construct.The patient previously had a 3 level alif (competitor products) and it was backed up by an l1/s1 construct using expedium 5.5 ti.The anterior cages did not fusing which caused a non-union.The surgeon was revising the posterior construct from t11 to l1 using expedium 5.5 ti and viper fenestrated.Surgeon was using viper fenestrated screws and confidence cement.At s1.The surgeon pumped cement through the screw at the left side of s1 and some of the cement leaked anteriorly of the s1 vertebral body.There was a surgical delay of five to ten (5 to 10) minutes.There were fragments generated.Patient status is unknown.The procedure was successfully completed.This complaint involves two (2) devices.This report is for (1) confidence kit, no needles this report is 2 of 2 for (b)(4).

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA
• MDR Report Key: 12102405
• MDR Text Key: 259589301
• Report Number: 1526439-2021-01377
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 75 YR