MAUDE Adverse Event Report: STRYKER GMBH L-PLATE, LEFT; PLATE, FIXATION, BONE

Catalog Number 40-15091S

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Metal Related Pathology (4530)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device discarded by the hospital.

Event Description

As reported: "the orif was performed for lisfranc injury on (b)(6), 2022.When the l-plate removal on (b)(6) 2024, the surgeon found that the peri-implant tissue became dark.While the removed plate was discarded at the facility.".

• Brand Name: L-PLATE, LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18838099
• MDR Text Key: 336908548
• Report Number: 0008031020-2024-00113
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540538734
• UDI-Public: 04546540538734
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 40-15091S
• Device Lot Number: 1000340309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 40 KG