MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE MTP, RIGHT ANCHORAGE; PLATE, FIXATION, BONE

Catalog Number PLP14342

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The pharmacist from the hospital reported the following event: "plate for arthrodesis mtp right foot 'asked the' (b)(6) 2016, found broken in the foot of the patient.Consequences of the incident: changing the plate (1 plate, 2 screws 18 and 2 screws 16).".

• Brand Name: CROSS PLATE MTP, RIGHT ANCHORAGE
• Type of Device: PLATE, FIXATION, BONE
• 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 Key: 8171046
• MDR Text Key: 130555753
• Report Number: 0008031020-2018-01071
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252260608
• UDI-Public: 07613252260608
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PLP14342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 80