MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX LATERAL HOOK PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from university hospital (b)(6).The title of this report is ¿a post-market clinical follow-up of the treatment of clavicle fractures and ac joint injuries with the variax clavicle locking plate system¿ which was published in january 2019 and is associated with stryker variax clavicle locking plate system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 1st january 2012 to 31st december 2017.It was not possible to ascertain specific device from the article; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 12 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses loss of reduction, revision surgery.The study states: "a (b)(6) man slipped while carrying furniture in (b)(6) 2013 and fell on his right shoulder.He contracted a lateral clavicle fracture which was treated with a lateral hook plate.The secondary diagnoses are chronic renal insufficiency in cystic kidneys, systolic dysfunction, diastolic dysfunction and mild concentric hypertrophy.The patient has neither osteoporosis nor diabetes and whether he smokes is not known.Initial surgery was performed without complications in (b)(6) 2013.After the osteosynthesis failure had been diagnosed (after 45 days), a material removal was performed at the end of (b)(6) 2013, followed by a new restoration with a new plate.In (b)(6) 2014 (237 days after the second restoration was inserted), the material was removed from the healed clavicle.

• Brand Name: UNKNOWN VARIAX LATERAL HOOK PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8704835
• MDR Text Key: 148271455
• Report Number: 0008031020-2019-00597
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 53 YR
• Patient Weight: 92