MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM

Catalog Number G6626526

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

Product code (ove): intervertebral fusion device with integrated fixation, cervical.The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Pre-revision x-rays for c5-6 acdf were provided.In each of the provided images, there is a globus interbody device and pseudoarthrosis.The inferior screw appears to violate the posterior vertebral body.By report, this was changed to medtronic system; but no images of that were made available.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-op diagnosis: cervical disc disease c5-c6 with radiculopathy type of procedure: anterior cervical discectomy and fusion (acdf) it was reported that on (b)(6) 2018, acdf was performed wherein globus implant was changed to medtronic implant.On an unknown date, post-op, the implant was found loose; and patient experienced pain.An x-ray was performed, which revealed posterior movement of the implant as compared to the x-ray performed on the day of the surgery ((b)(6) 2018).On (b)(6) 2018, the patient presented for surgery.The loosened implant was removed and replaced with a titanium cage with a plate.The surgery went well and showed that there was likely a fusion inside the bonefilled implant as well as at one of the endplates.On the other endplate, there was like a pseudoarthrosis.The screws were normally withdrawn.The surgeons had to use a bur when withdrawing the implant, due to the partially bony fusion.After the removal, the surgeon cleaned up the space and placed a titanium cage with a titanium plate.The surgeon believes that the cage migrated posterior due to his own faults.The surgeon felt that he removed quite a lot of osteophytes and maybe took out too much bone anteriorly.The surgeon could not recognize anything on the cage or around it.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: visual and optical review confirmed the top portion of the implant is broken off.Witness marks and deformation of the locking tab is noted.Additionally, deformation is noted at the radius of the inserter tab interfaces.Sections of the corners or the implant have been broken off.The broken pieces were not returned with the implant.The above observations are consistent with brittle overload during insertion and additional damage being done upon removal of the implant as the mechanism of failure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7899527
• MDR Text Key: 121434655
• Report Number: 1030489-2018-01273
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 00643169337497
• UDI-Public: 00643169337497
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K141599
• 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,Followup
• Report Date: 11/30/2018

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: Health Professional
• Device Catalogue Number: G6626526
• Device Lot Number: H5414622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 08/23/2018; 11/26/2018
• Supplement Dates FDA Received: 09/21/2018; 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2018
• 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): Required Intervention
• Patient Age: 50 YR