MAUDE Adverse Event Report: STRYKER GMBH STEINMANN PIN, SMOOTH, 2.5MMX100MM; PLATE, FIXATION, BONE

Catalog Number 45-80300

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

This event was reported through an attorney, as a result of a legal claim.Due to the ongoing litigation no additional information is available at this time.If additional information is received it will be reported on a supplemental report.

Event Description

Allegedly the patient underwent foot surgery in (b)(6) 2018 with stryker components and subsequently had the hardware removed in (b)(6) 2018.Patient alleges she had a reaction to the material compositions of these systems which resulted in alleged injury of complex regional pain syndrome (crps).

Event Description

Allegedly the patient underwent foot surgery in (b)(6) 2018 with stryker components and subsequently had the hardware removed in (b)(6) 2018.Patient alleges she had a reaction to the material compositions of these systems which resulted in alleged injury of complex regional pain syndrome (crps).

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise, the investigation will be updated accordingly.

• Brand Name: STEINMANN PIN, SMOOTH, 2.5MMX100MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8359051
• MDR Text Key: 136839419
• Report Number: 0008031020-2019-00073
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540605511
• UDI-Public: 04546540605511
• Combination Product (y/n): N
• PMA/PMN Number: K063875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 45-80300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention