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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ANCHORAGE CP PLATE LAPIDUS IMPLANT

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STRYKER GMBH UNKNOWN ANCHORAGE CP PLATE LAPIDUS IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2019
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device disposition is unknown. Additional information has been requested and if received, will be provided in the supplemental report.
 
Event Description
Customer reported that the plate was selected for surgery and when opening the corresponding sterile plate from its packaging, the implants was not as described on the packaging. Customer reported that they were looking to use a lapidus cp plate 0 ¿ however, upon opening the packing, there appears to be a mtp v1 long in the packaging.
 
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Brand NameUNKNOWN ANCHORAGE CP PLATE LAPIDUS
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 Key8414712
MDR Text Key138932002
Report Number0008031020-2019-00243
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received02/28/2019
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: 03/12/2019 Patient Sequence Number: 1
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