MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number UNK - BIO - PREFORMED: CHRONOS

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 01/02/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown unk - biomaterial - preformed: chronos: spine /unknown lot.Part and lot number are unknown.Without the specific part number; the udi 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that report is being filed after the review of the following journal article: huang, c.Et al.(2020), comparison of patient-reported postoperative dysphagia in patients undergoing one-level versus two-level anterior cervical discectomy and fusion with the zero-p implant system, dysphagia, vol.Xx, pages 1-11 ((b)(6)) the purpose of this retrospective study based on 208 patients was (1) to investigate whether the incidence of postoperative dysphagia differs between one-level and two-level acdf with the zero-p and (2) to examine patient characteristics that may be associated with the occurrence of dysphagia after acdf with the zero-p.Between january 2013 and december 2018, a total of 208 patients underwent acdf.86 patients underwent one-level acdf while 122 patients underwent two-level acdf.There were 122 males and 86 females.The implants used were the zero-p and implant filled with a composite synthetic bone graft (chronos).The zero-p consists of three major parts: a titanium alloy plate, a poly-etherether- ketone (peek) interbody spacer, and four locking head screws.The average follow-up period of 18 months (ranging from 12 to 24 months).The following complications were reported as follows: one-level: 17 patients had mild dysphagia postop.8 patients had moderate dysphagia postop.3 patients had severe dysphagia postop.Two-level: 82 patients had mild dysphagia postop.26 patients had moderate dysphagia postop.12 patients had severe dysphagia postop.A (b)(6) male patient had experienced severe dysphagia at 1 week and 1 month after surgery.The patient reported no dysphagia at 3 months.A (b)(6) female patient showed mild dysphagia at 1 week and no dysphagia at 1 month after surgery.This report is for an unknown biomaterial - preformed: chronos: spine.This report is for one (1) unk - constructs: zero-p.This report is 2 of 6 for (b)(4).A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Product complaint # (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.H3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned for investigation.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.

• Brand Name: UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11660976
• MDR Text Key: 261438915
• Report Number: 8030965-2021-02863
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - BIO - PREFORMED: CHRONOS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention