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

Catalog Number	628027
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Variax clavicle device implanted on (b)(6) 2019.Revision surgery (scheduled (b)(6) 2019) required due to poor fixation.
Additional Manufacturer Narrative
The reported event could not be confirmed.The given feedback indicated though that the patient suffered from bone fragment metastasis.Based on the given information, the root cause was attributed to be patent related (all returned implants are still intact).The failure was caused by the indication of the bone fragment metastasis.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Variax clavicle device implanted on (b)(6) 2019.Revision surgery (scheduled (b)(6) 2019) required due to poor fixation.

• 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: 8448157
• Report Number: 0008031020-2019-00299
• Device Sequence Number: 3013781
• Product Code: HRS
• UDI-Device Identifier: 07613252441953
• UDI-Public: 07613252441953
• Combination Product (Y/N): N
• 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): 04/16/2019

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: L52243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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