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U.S. Department of Health and Human Services

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

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STRYKER GMBH UNKNOWN AXSOS PLATE PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNK_SEL
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Impaired Healing (2378)
Event Date 05/06/2022
Event Type  Injury  
Event Description
It was reported that a patient had surgery and has not been progressing as well as they should with healing. After an x-ray it is shown that the screws have come away from the implanted plate and the plate has come off of the bone. Patient is potentially awaiting revision but unconfirmed. It is noted that the surgeon used an axos plate with variax screws for the surgery.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report. Device remains implanted in patient.
 
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Brand NameUNKNOWN AXSOS PLATE
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 Key14691011
MDR Text Key294022630
Report Number0008031020-2022-00281
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
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
Date Manufacturer Received05/20/2022
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: 06/14/2022 Patient Sequence Number: 1
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