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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SPS SMALL FRAGMENT T-PLATE STAINLESS STEEL; IMPLANT

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STRYKER GMBH UNKNOWN SPS SMALL FRAGMENT T-PLATE STAINLESS STEEL; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Irritation (1941)
Event Date 07/01/2014
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device evaluated by mfr: device disposition is unknown.
 
Event Description
The manufacturer became aware of a post-market clinical follow-up (pmcf) from university hospitals (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the internal fracture fixation of long bones with the stryker plating system (sps)¿ which was published in june 2019 and is associated with the stryker plating system (sps).Within that publication, post-operative complications/ adverse events were reported which occurred between july 2014 to july 2018.It was not possible to ascertain specific device or patient information from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 22 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses prominence of metalwork.4 out of 4 cases.Removal of hardware due to prominence and irritation of the soft tissue the pmcf report states, ¿cloverleaf applied to the medial malleolus of the tibia for a vertically oriented shear fracture, the fracture united and was subsequently removed due to prominence and irritation of the soft tissue at 228 days post implantation.The patient remains under follow up but radiographically a good outcome has been achieved.[¿] prominence of metalwork is in the authors experience often more likely due to patient factors than the design of the plate¿.
 
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Brand Name
UNKNOWN SPS SMALL FRAGMENT T-PLATE STAINLESS STEEL
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH   2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8847406
MDR Text Key152908172
Report Number0008031020-2019-00968
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/31/2019
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 07/18/2019
Initial Date FDA Received07/31/2019
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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