MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; ANTERIOR TRIAL SPACER

Catalog Number UNK CAGE/SPACER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

(b)(6) this report is for an unknown cage-spacer/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: zero-profile anchored spacer reduces rate of dysphagia compared with acdf with anterior plating authors: christoph p.Hofstetter, md, phd, kartik kesavabhotla, bs, and john a.Boockvar, md citation: j spinal disord tech 2015;28:e284¿e290.(usa).The aim of this retrospective cohort study is to report clinical and radiologic outcomes after anterior cervical discectomy and fusion (acdf) using a zero profile anchored spacer compared with a standard interposition graft with anterior plating.From october 2007 and april 2011, 70 consecutive patients with the mean age of 54.1 years (range, 29¿82) and was comprised of 34 males and 36 females were included in the study.The first 35 patients underwent anterior cervical discectomy and fusion (acdf) with anterior plating and the remaining patients received a zero-profile anchored spacers (ldr) device.During the operation, the patient who underwent acdf received a depuy carbon-fiber cage (bengal, depuy synthes) combined with an anterior plate (skyline, depuy synthes).The wound was irrigated and closed in the standard manner.Patients received standard postoperative care including postoperative antibiotics for 24 hours, appropriate analgesic medication, as well as gastric ulcer and deep venous thrombosis prophylaxis.Complications included swallowing difficulties (dysphagia) (<3 mo) n=14, swallowing difficulties (>3 mo) n=7, and new neurological deficit n=1.In conclusion, zero-profile anchored spacers lead to similar clinical and radiographic outcomes compared with acdf with plating and may carry a lower risk of postoperative dysphagia.The following complications were reported as follows: intraoperative csf leaks were successfully repaired with small muscle grafts obtained from the longus colli muscle followed by dura seal." further, they noted that "there were no intraoperative complications".Dysphagia and neurologic difficulties were common postoperative complications that can be attributed to the procedure or with the use of the device, thus these were captured as events." this report is for one (1) unknown cage/spacer.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Surgical intervention in the form of revision surgery.

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: ANTERIOR TRIAL SPACER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9430919
• MDR Text Key: 187689111
• Report Number: 1526439-2019-52617
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CAGE/SPACER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention