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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V2 - RIGHT PLATE, FIXATION, BONE

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STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V2 - RIGHT PLATE, FIXATION, BONE Back to Search Results
Model Number PLP11342
Device Problems Material Fragmentation (1261); Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device remains in the patient.
 
Event Description
As reported: "primary procedure, right first mtp. It was reported that when the drill guide was seated into a hole of the plate and after drilling was done, a thread-like piece of metal was seen in the patient. The piece was removed by the surgeon. Surgeon reported that it felt as though the drill guide did not seem to be seating as deeply in the hole as it had in the previous holes, and believes that the thread of metal was shaved off of the plate while drilling. Procedure was completed successfully with no delay. ".
 
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Brand NamePLATE ANCHORAGE MTP / VERSION V2 - RIGHT
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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11229114
MDR Text Key232523589
Report Number0008031020-2021-00029
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPLP11342
Device Catalogue NumberPLP11342
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 Received01/12/2021
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

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