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

Catalog Number	45-80300
Health Effect - Clinical Code	Reaction (2414)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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).
Additional 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8359051
• Report Number: 0008031020-2019-00073
• Device Sequence Number: 2017807
• Product Code: HRS
• UDI-Device Identifier: 04546540605511
• UDI-Public: 04546540605511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 45-80300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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