MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX 2 VOLAR PLATE; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "revision surgery related to pi#3238316.Variax2 volar plate was placed on (b)(6) 2023.Patient had pain, x ray showed on 15-4-2023 that the variax volar plate was broken.Possible cause: too much weight lifted, plate is to thin and maybe galleazi# revision is done with a axsos3 4.0 compression plate".

Manufacturer Narrative

After gathering additional information, it was noted that this event is a duplicate record of mfr report#: 0008031020-2023-00201.The event details and investigation will be captured in the respective mfr report#.Therefore, this will record will subsequently be closed.

Event Description

As reported: "revision surgery related to (b)(4).Variax2 volar plate was placed on (b)(6)2023.Patient had pain, x ray showed on (b)(6) 2023 that the variax volar plate was broken.Possible cause: too much weight lifted, plate is to thin and maybe galleazi# revision is done with a axsos3 4.0 compression plate.".

• Brand Name: UNKNOWN VARIAX 2 VOLAR PLATE
• Type of Device: PLATE, 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17073072
• MDR Text Key: 316749774
• Report Number: 0008031020-2023-00216
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2023
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 104 KG