MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK CAGE/SPACER: EIT - TLIF; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problem Device-Device Incompatibility (2919)

Patient Problems Cerebrospinal Fluid Leakage (1772); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk cage/spacer: eit - tlif/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.(b)(4).The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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) 2020, the patient underwent for a back surgery to repair several lumbar conditions including disc herniations, sciatica and lumbar stenosis.Surgery was performed using a depuy synthes transforaminal lumbar interbody fusion cage between two of the patient's lumbar vertebra using a stylet.The surgeon attempted multiple times to detach the stylet from the cage, but the defective cage would not allow the stylet to be detached and because of that the surgeon was forced to remove the entire cage for reinsertion.Upon removal of the defective depuy synthes tlif cage, the patient suffered a durotomy of the nerve root, cerebrospinal fluid leak and dropped foot and the cage was not reinserted.The routine two-hour surgery ballooned into an eight-hour procedure where the surgeon attempted to repair the damage caused by the defective depuy synthes tlif cage.Serious health complications resulted from the failure of the defective cage including a blood clot in the patient's right calf, infection, and significant and continuous pain.This complaint involves one (1) device only.This report is for (1) unk cage/spacer: eit - tlif.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D11: concomitant products added to complaint.H6: investigation summary: 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

Update: additional information provided by legal.

• Brand Name: UNK CAGE/SPACER: EIT - TLIF
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11088977
• MDR Text Key: 224273012
• Report Number: 1526439-2020-02491
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Patient Sequence Number: 1
• Treatment: UNK CAGE/SPACER: EIT - TLIF
• Patient Outcome(s): Required Intervention