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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL POLYMETHYLMETHACRYLATE BONE CEMENT

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OBERDORF SYNTHES PRODUKTIONS GMBH SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 07.702.016S
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Non-union Bone Fracture (2369); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Event year reported as 2018; however exact date of cement leakage is unknown. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (510k): device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that the vertecem v+ cement was ended up to patient's superior vena cava after injected to the patient's two vertebras. Initially, the patient underwent a spinal procedure on december 11, 2018. There was a 1. 5 cc cement volume per pedicle. Procedure performed following vertecem v+ surgical technique, which is familiar to surgeons and or-staff involved. Injection started 6 minutes after mixing the cement. There was no information about the revision surgery as of this time. This report is for one (1) vertecem v+ cement kit. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameSISTEMA DE CEMENTO VERTECEM V+ . ESTERIL
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8264759
MDR Text Key133706022
Report Number8030965-2019-60123
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Catalogue Number07.702.016S
Device Lot Number8C53231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/21/2019 Patient Sequence Number: 1
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