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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX PINS; PIN, FIXATION, THREADED

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STRYKER GMBH UNKNOWN APEX PINS; PIN, FIXATION, THREADED Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 05/01/2017
Event Type  Injury  
Event Description
The manufacturer became aware of a literature published by the ¿centre ostéo-articulaire des cèdres, échirolles, france¿.The title of this report is ¿arthroscopic arthrodesis of the shoulder in brachial plexus palsy¿, published on may 01, 2017.Which is associated with the stryker ¿hoffman external fixation system¿.The article can be found at http://dx.Doi.Org/10.1016/j.Jse.2016.09.040.This report includes an analysis of the clinical data that was collected on 8 patients.The cases in this study range from february 2012 to august 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced poor tolerance of the external fixator under the skin, which required revision.The report states, ¿one acromiohumeral screw was removed together with the external fixator because it was poorly tolerated.¿.
 
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event regarding the poor tolerance of the external fixator under the skin, which required revision, could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
 
Manufacturer Narrative
Please note correction to suspected medical device in section d.This includes the following; product long description, product code, and common device name.This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of poor tolerance of external fixator under the skin, which required revision could not be confirmed, since no additional information was received from the author or the article.More detailed information about the patient medical history, the event circumstances, and medical reports must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
 
Event Description
The manufacturer became aware of a literature published by the ¿centre ostéo-articulaire des cèdres, échirolles, france¿.The title of this report is ¿arthroscopic arthrodesis of the shoulder in brachial plexus palsy¿, published on may 01, 2017.Which is associated with the stryker ¿hoffman external fixation system¿.The article can be found at http://dx.Doi.Org/10.1016/j.Jse.2016.09.040.This report includes an analysis of the clinical data that was collected on 8 patients.The cases in this study range from february 2012 to august 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced poor tolerance of the external fixator under the skin, which required revision.The report states, ¿one acromiohumeral screw was removed together with the external fixator because it was poorly tolerated.¿.
 
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Brand Name
UNKNOWN APEX PINS
Type of Device
PIN, FIXATION, THREADED
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ   2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14863634
MDR Text Key295111926
Report Number0008031020-2022-00305
Device Sequence Number1
Product Code JDW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/08/2022
Initial Date FDA Received06/29/2022
Supplement Dates Manufacturer Received07/20/2022
Supplement Dates FDA Received08/18/2022
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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