MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 6 HOLE / 16MM / LEFT; PLATE, FIXATION, BONE

Catalog Number 628526S

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2024

Event Type  Injury  

Event Description

As reported: the patient's bone quality was fragile.And the plate was dislodged from the bone along with the screws.Revision surgery is planed on (b)(6) 2024.

Manufacturer Narrative

Based on the available information, the device will not be returned.Therefore, an evaluation of the device cannot be performed.A review of the device history is not possible, because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text: device owned by the patient.

Manufacturer Narrative

Please note corrections to section h6 (method code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "the patient's bone quality was fragile and the plate was dislodged from the bone along with the screws.Revision surgery is planed on (b)(6) 2024.".

• Brand Name: HOOK PLATE VARIAX CLAVICLE 6 HOLE / 16MM / LEFT
• 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: 18738940
• MDR Text Key: 335754576
• Report Number: 0008031020-2024-00108
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327085549
• UDI-Public: 07613327085549
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 628526S
• Device Lot Number: AA2089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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