MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 HOLE / RIGHT; PLATE, FIXATION, BONE

Catalog Number 628027

Device Problem Break (1069)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.

Event Description

It was reported that the patient's right clavicle was revised.Patient fell out of a chair, broke the existing variax plate, and lost reduction.Patient was revised to another variax plate.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.It is reported that the patient fell out of a chair and broke the existing variax plate.As informed in the implant ifu: ¿these devices are intended only to assist healing and are not intended to replace normal bone structures.No fracture fixation device that is subject to material fatigue can be expected to withstand activity levels in the same way as would a normal healthy bone." based on investigation, the root cause was attributed to a user related issue.The failure was caused by the patient's fall.If any further information is provided, the complaint report will be updated.

Event Description

It was reported that the patient's right clavicle was revised.Patient fell out of a chair, broke the existing variax plate, and lost reduction.Patient was revised to another variax plate.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 HOLE / RIGHT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8898804
• MDR Text Key: 154705238
• Report Number: 0008031020-2019-01054
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252441953
• UDI-Public: 07613252441953
• Combination Product (y/n): N
• PMA/PMN Number: K113760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 628027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention