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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PLATE; IMPLANT
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STRYKER GMBH UNKNOWN PLATE; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problems Positioning Failure (1158); Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
 
Event Description
As reported: "angular stability did not work.Screws have overrun and chips have come loose under the screw head (unfortunately, chips could not be secured).Replacement was available.Patient involvement was reported but the reporter is not aware of any impact.".
 
Manufacturer Narrative
For locking issues, variax2 screws are considered as contributing to the reported failure.The subject device (plate) is considered as concomitant and did not contribute to the reported failure as per investigation.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
Event Description
As reported: "angular stability did not work.Screws have overrun and chips have come loose under the screw head (unfortunately, chips could not be secured).Replacement was available.Patient involvement was reported but the reporter is not aware of any impact.".
 
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Brand Name
UNKNOWN PLATE
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key10586223
MDR Text Key209192282
Report Number0008031020-2020-02267
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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