MAUDE Adverse Event Report: MSD DEGGENDORF MFG VERTE-STACK SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 6240841

Device Problems Device Expiration Issue (1216); Migration or Expulsion of Device (1395); Off-Label Use (1494); Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); Choking (2464); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported via medwatch form, that the surgeon performed a two level anterior cervical discectomy at c4-c5.Reportedly, "post-op complications were dysphagia, dysphonia, choking, difficulty swallowing, loss of feeling in the hands, fingers, and arms patient will be undergoing revision surgery shortly".Allegedly," expired and mislabeled product was implanted".

Manufacturer Narrative

Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported via medwatch form that the patient was implanted with corpectomy cages into the cervical spine.Post-op, imaging showed that one of the two cages dislocated and migrated into the spinal canal.Patient will require revision surgery.Also the product was already expired in 2010 and implanted in 2011.

Manufacturer Narrative

Additional information: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Although it has been reported that the implant was past its expiration date when it was implanted into the patient, the expiry date was found to be in the year 2019 corresponding to the reported lot number.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported per social media posts that the patient underwent cervical discectomy and fusion at c4-c7.As per the post, the patient was implanted with a peek device that was used in an off-labeled manner in patient's neck.The patient alleged that the peek device was past its expiration date when it was implanted in her cervical spine.She was also implanted with a cervical plate, fixed screws and variable screws in this surgery.Two weeks post-op, reportedly, she felt something wrong with the implant.The doctor ensured that she was fine and just needed drugs.Reportedly, the patient could not walk anymore.She later found out when the radiologist confirmed that her implant had migrated posteriorly into her spinal canal.It appeared that the patient underwent more than one spinal surgery.One of the patient's post also alleged that she underwent 4 surgeries.

Manufacturer Narrative

Radiological images review: multiple images provided for patient with complex history of cervical spinal surgery and revision surgery.Mri of cervical spine, lumbar x-ray, post-op x-ray with anterior/posterior instrumentation, ct of cervical spine, axial ct of thoracic spine, sagittal ct of thoracic spine were provided.There appears to be junctional failure above and below the anterior cervical fusion construct with spinal cord impingement on a sagittal spine ct.There appears to be posterior displacement of an interbody graft.One of the thoracic pedicle screws extends through the vertebral body.An incomplete history and chronology of surgical events was provided for this case.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTE-STACK SPINAL SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6957316
• MDR Text Key: 89566638
• Report Number: 1030489-2017-02226
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00613994305091
• UDI-Public: 00613994305091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2019
• Device Catalogue Number: 6240841
• Device Lot Number: TZ32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 10/25/2017; 10/16/2019; 04/10/2020
• Supplement Dates FDA Received: 11/17/2017; 11/11/2019; 04/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2011
• 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; Required Intervention