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

Catalog Number	628027
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8898804
• Report Number: 0008031020-2019-01054
• Device Sequence Number: 16548717
• Product Code: HRS
• UDI-Device Identifier: 07613252441953
• UDI-Public: 07613252441953
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 628027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention