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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 Problem Material Erosion (1214)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
It was reported a locking screw was inserted into the distal locking hole, but it was unable to lock and was spinning, and a small piece of metal was seen (whether it was the plate side or the screw side).The hole could not be used, and the other screw was used in the other hole, but it was still idle and could not be locked.After that, when a new screw was used, locking was possible without issue.
 
Event Description
It was reported a locking screw was inserted into the distal locking hole, but it was unable to lock and was spinning, and a small piece of metal was seen (whether it was the plate side or the screw side).The hole could not be used, and the other screw was used in the other hole, but it was still idle and could not be locked.After that, when a new screw was used, locking was possible without issue.
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device is not available for return, device is still implanted.
 
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Brand Name
UNKNOWN PLATE
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key9329142
MDR Text Key174296952
Report Number0008031020-2019-01678
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 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Returned to Manufacturer11/06/2019
Initial Date Manufacturer Received 10/17/2019
Initial Date FDA Received11/15/2019
Supplement Dates Manufacturer Received12/03/2019
Supplement Dates FDA Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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