MAUDE Adverse Event Report: INION OY INION CPS¿ BABY; BONE SCREW

Model Number	1
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No other similar complaints have been received for this product batch, and a review of the batch manufacturing records confirmed that the product batch is in specification.The occurrence rate of inion cps baby screw breakage during insertion was evaluated and determined to be very low.The difficulties related to screw handling and placement, which contributed to an extended surgical time, were assessed and determined to be associated with deviation from the screw picking and placement technique described in the inion cps baby instructions for use (ifu).The recommended technique outlined in the ifu may not have been followed in this case.It is also recognized that the use of inion cps baby screws involves a learning curve, as the bioabsorbable material properties differ from those of traditional titanium screws, resulting in different insertion characteristics.The surgeon was a first-time user to the inion cps baby system.Residual risks related to screw breakage and other problems during insertion are identified in the risk analysis of the inion cps and inion cps baby and presented in the inion cps baby instructions for use.
Event or Problem Description
During a surgery in a hospital, the user had problems with the inion cps baby screws (two screw sizes, refs reported separately).There was a 60-minute delay in a patient's cranial operation due to screw picking problems from the screw ring (it was reported that the screws did not stick to screwdriver and screws dropped from the screwdriver after picking) and screw placement problems (screws broke during insertion).Besides the 60-minute delay, no other patient harm was reported.The surgery was completed by using inion cps baby screws.

• Brand Name: INION CPS¿ BABY
• Common Device Name: BONE SCREW
• Manufacturer (Section D): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer (Section G): INION OY; lääkärinkatu 2; tampere, 33520 ; FI 33520
• Manufacturer Contact: kati marttinen ; lääkärinkatu 2; tampere, 33520 ; FI 33520
• MDR Report Key: 24002142
• Report Number: 3003407235-2026-00001
• Device Sequence Number: 18688265
• Product Code: HWC
• UDI-Device Identifier: 06438408000133
• UDI-Public: 06438408000133
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K010351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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: 1
• Device Catalogue Number: SCR-1220
• Device Lot Number: 2506014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male