MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY

Model Number 283910000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes sales representative.A photo investigation was completed: the complaint device was not received for investigation.A photo investigation was performed based on the provided image.The image was reviewed, and the complaint condition cannot be confirmed.There is no evidence of cement leakage in the provided radiograph.A definitive assignable root cause could not be determined based on the provided information.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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

Device report from synthes (b)(6) reports an event as follows: during a lumbar stabilization revision, after replacing an expedium screw with a cortical fix screw, there was a small cement leakage in the canal during the introduction of the confidence cement.Radiologically, the cement did not come out of the holes on the implanted screw.This report is for the intra-operative issue with the confidence cement.This is report 1 of 1 for (b)(4).The need for the revision procedure is captured in related complaint (b)(4).

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• 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 02767 ; 6103142063
• MDR Report Key: 12341528
• MDR Text Key: 267237384
• Report Number: 1526439-2021-01725
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: (01)10705034209623
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283910000
• Device Catalogue Number: 283910000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FEN OPEN CANNULA STRL; MIS TI CFX FEN POLY 8X55