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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
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.
 
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 (china) 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) year-old 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) year-old 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 4 of 6 for (b)(4).
 
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Brand NameUNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 
MDR Report Key11660951
MDR Text Key245875621
Report Number8030965-2021-02865
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
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 Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - BIO - PREFORMED: CHRONOS
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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