MAUDE Adverse Event Report: INION OY INION CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM; BONE SCREW

Model Number	SCR-2225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cellulitis (1768); Foreign Body Reaction (1868)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inion cps 2.0 4-hole plate and 2x7mm screws were used for fixation after intraorbital tumor resection in (b)(6)-year old patient (i.E., pediatric patient).Six days postoperatively there was redness and swelling of the upper eyelid accompanied by pus in the lateral canthus.Treatment with intravenous antibiotics did not resolve the problem.It is unclear whether bacterial culture was made before choosing the antibiotic (ceftriaxone sodium).Approximately 3 weeks postoperatively reoperation number 1 was carried out for abscess incision and drainage.3 months later (i.E., approximately 4 months and 10 days after the original tumor resection operation and implantation of the inion cps implants) problems reoccurred with orbit skin ulceration and cellulitis inflammation.Two weeks later (i.E., nearly 5 months after the original tumor resection operation and implantation of the inion cps implants) reoperation number 2 was carried out for implant removal and debridement.Most likely the initial cause of the complications experienced by the above described patient was bacterial infection.The patient was treated with intravenous antibiotics (ceftriaxone sodium) initially but that didn't solve the problem.The early onset of symptoms (6 days postoperatively) indicates bacterial infection (or possibly swelling due to surgical trauma) rather than tissue reaction related to the implant material because typically implant material degradation related inflammatory tissue reactions occur much later, i.E., typically 1-2 years postoperatively in case of the inion cps implants, and only very rarely as early as 0,5-1 years after implantation).
Event or Problem Description
Right intraorbital tumor resection for (b)(6) year old female patient was operated.Redness and swelling developed 6 days after the operation.There was no significant improvement after intravenous infusion of ceftriaxone sodium, so "orbit sidewise opening of the right eye, intraorbital abscess incision and drainage, orbital septum repair, eyelid suture" were carried out 3 weeks post operatively.4 months after the initial operation,the skin of the right orbit was ulcerated.The diagnosis was "right orbit cellulitis inflammation".And revision surgery was performed.At implant removal granulation-like tissue hyperplasia was seen and removed, the soft tissue near the absorbable plate was eroded and brittle.There was no obvious infection in the exploration, and the outer orbital bone was healed well.

• Brand Name: INION CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
• Common Device Name: BONE SCREW
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• MDR Report Key: 11559134
• Report Number: 3003407235-2021-00001
• Device Sequence Number: 4766672
• Product Code: HWC
• UDI-Device Identifier: 06438408001185
• UDI-Public: 06438408001185
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: Health Professional
• Device Model Number: SCR-2225
• Device Catalogue Number: SCR-2225
• Device Lot Number: 2005003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/24/2021
• 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
• Patient Age: 6 YR
• Patient Weight: 22