• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS LOCKING COMPRESSION PLATE NARROW 7 HOLE/L133MM IMPLANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER GMBH UNKNOWN AXSOS LOCKING COMPRESSION PLATE NARROW 7 HOLE/L133MM IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Non-union Bone Fracture (2369)
Event Date 08/06/2020
Event Type  Injury  
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 any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from the university of (b)(6), in usa. The title of this report is ¿a retrospective data collection of the internal fixation, stabilization and support of fractures, and bone fixation after osteotomies with the axsos locking plate system¿ which is associated with the stryker ¿axsos locking plate¿ system. This study includes research done on 50 patients requiring surgery between the period september 2018 and december 2019. It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints. Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report. This product inquiry addresses nonunion of mid-shaft humerus fracture (no radiographic and clinical consolidation) requiring reoperation with reverse total shoulder arthroplasty. The report states: ¿in our analysis we define radiographic bone consolidation as 3 of 4 cortices showing no evidence of a fracture line and clinical consolidation as fully weight bearing with no pain. We also defined delayed union as 3 months with no evidence of significant bone formation and nonunion as a documented visible fracture line with no evidence of healing and clinic documentation if available of pain at 6 months. Ninety-four percent of the cases resulted in radiographic consolidation and 92% of the cases resulted in clinical consolidation, while 6% went on to delayed or nonunion one was a nonunion. This patient was treated with an axsos implant due to a shoulder arthroplasty periprosthetic fracture. The nonunion lead to reoperation with a reverse total shoulder arthroplasty. The delayed union and nonunions were not due to device related events as the plates and screws did not break or cause any issues. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN AXSOS LOCKING COMPRESSION PLATE NARROW 7 HOLE/L133MM
Type of DeviceIMPLANT
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 Key10493937
MDR Text Key206181723
Report Number0008031020-2020-02210
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
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: 09/04/2020 Patient Sequence Number: 1
-
-