MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CHARITE ARTIFICIAL DISC; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number 75640614

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 06/26/2015

Event Type  Injury  

Manufacturer Narrative

The charite artificial disc (product code: 7564-0614, lot number: unknown) was returned to the complaints handling unit (chu).The images returned with this disc show that the disc had migrated anteriorly and there is spondylolisthesis at the level at which this occurred.This is most readily visible in (b)(4) x-ray 1 received 13 july 2015.However, the x-ray images returned are not of the spine prior to the insertion of the disc.It is difficult to determine a frame of reference without images prior to the original surgery.The two endplates of the disc each feature some damage.One features a tooth that is bent down in towards the surface of the endplate.The rough metallic surface also features wear at two separate corners to the degree that the smoother surface of the plate beneath has become exposed.The other endplate features a single broken tooth as well as signs of abrasion in the general area of this broken tooth.The break appears to be a brittle failure based on the significant amount of jagged area across the surface of the break.Both plates also feature minor scratches upon both sides that are not believed to be significant enough to have interfered with the function of the device.There is no indication as to when the broken tooth broke and the bent tooth bent.The returned x-ray images show that all of the teeth of the plates are intact.Without exact information regarding the configuration of the endplates, it is not possible to determine if the teeth of the endplates were in good condition prior to being explanted.It is possible that the teeth were damaged upon extraction.This is partially supported by the returned images, but is also supported by the areas of abrasion on the surface of the endplates near the broken/bent teeth.This abrasion is not believed to be typically experienced, and may have been a product of forceful removal of the endplates.The force required to remove them may have been necessitated by the amount of time the endplates had been implanted in the patient¿s body.There is no indication that the broken piece of tooth or potential debris from the rough surface of the endplate were left in the patient postoperatively.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.No emerging trends were found requiring further actions the root cause of the disc migrating postoperatively cannot be determined at this time from the sample and the information provided.A possible root cause cannot be determined using the available information.There is no indication that the teeth were damaged prior to the revision surgery.There is no indication that the broken piece was left in the patient after removing the disc.However, the preoperative x-rays do show that the poly core did migrate after the charite disc was originally implanted.It has been noted that charite technology was not owned by a johnson & johnson affiliated organization until 2003.Information regarding charite discs manufactured prior to this date is not readily available.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.

Event Description

Revision of charite, alif and translatminar screws performed on (b)(6) 2015 by dr (b)(6) at (b)(6) hospital.Reason for revision; return of back and leg pain.Patient had link sb charite lumbar disc replacement implanted outside of (b)(6) 15 years ago.Central core of charite was no longer within the metal end plates.Charite was replaced with cougar 2 cage and aegis plate.Patient then had 2 translaminar facet screws to provide posterior stabilisation.Patient outcome post surgery; patient is awake and neurologically intact.Pre-op ap and lateral x-rays, and post op x-ray are available.Patient details; (b)(6) female.(b)(6).

• Brand Name: CHARITE ARTIFICIAL DISC
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5055854
• MDR Text Key: 24988890
• Report Number: 1526439-2015-10776
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 75640614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR