MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN JOINT-BRIDGING, EXTERNAL FIXATOR; IMPLANT

Catalog Number UNK_SEL

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device disposition is unknown.

Event Description

Patient had suffered a fracture of the lower leg on (b)(6) 2019.At the (b)(6), the patient was fitted with a joint-bridging, external stryker fixator.The osteosynthesis material was broken in (b)(6) 2019.

• Brand Name: UNKNOWN JOINT-BRIDGING, EXTERNAL FIXATOR
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10123377
• MDR Text Key: 194163019
• Report Number: 0008031020-2020-01550
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: DE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/05/2020
• 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: 64 YR