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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STEINMANN PIN PLATE, FIXATION, BONE

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STRYKER GMBH UNKNOWN STEINMANN PIN PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNK_SEL
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 11/22/2014
Event Type  Injury  
Event Description
The manufacturer became aware of a literature published by the ¿clinic for technical orthopedic surgery, university hospital of muenster, germany ¿. The title of this report is ¿clinical benefit and improvement of activity level after reconstruction surgery of charcot feet using external fixation: 24-months results of 292 feet ¿, published on november 22, 2014. Which is associated with the stryker ¿hoffman ii external fixation system¿. The article can be found at http://www. Biomedcentral. Com/1471-2474/15/392. This report includes an analysis of the clinical data that was collected on 282 patients. The cases in this study range from 1996 to 2010. 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 3 patients experienced pin failure/dislocation.
 
Manufacturer Narrative
This record is a consolidation of events summarized as part of literature review when device and patient information is not available. This complaint has been generated based on findings discovered during post market surveillance literature review. The alleged event of pin failure/dislocation 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.
 
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Brand NameUNKNOWN STEINMANN PIN
Type of DevicePLATE, FIXATION, BONE
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 Key14863957
MDR Text Key295069194
Report Number0008031020-2022-00309
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2022
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 Treatment Data
Date Received: 06/29/2022 Patient Sequence Number: 1
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