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

Catalog Number	628536S
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The patient underwent variax clavicle surgery for right clavicle on (b)(6) 2018.The plate was removed without the bone union on (b)(6) 2018 due to the erosion of the hook to acromion.

• Brand Name: HOOK PLATE VARIAX CLAVICLE 6 HOLE / 16MM / RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7691502
• Report Number: 0008031020-2018-00504
• Device Sequence Number: 11408056
• Product Code: HRS
• UDI-Device Identifier: 07613327085570
• UDI-Public: 07613327085570
• Combination Product (Y/N): N
• PMA/510(K) Number: K140259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2018

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: 628536S
• Device Lot Number: L15592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/16/2018
• 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