MAUDE Adverse Event Report: I.T.S. GMBH BIPLANAR 2-COLUMN PLATE, 12-HOLE, LEFT, PRS PHOENIX

Model Number	21216-12
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Malunion of Bone (4529)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no lot no.Was provided we have inspected the dhf of all lots supplied to the hospital including material certificate and the batch was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The article met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The patient was not able to comply with the post-operative instructions caused by the anesthesia and loaded the hip significantly more than the specifications would have allowed.This also shifted the fragments of the acetabular fracture, the fracture healed bony.However, because the fracture healed in malunion and because it was a severe injury, the patient developed early hip osteoarthritis and was treated with a total hip arthroplasty.Based on the information available, it has been determined that no corrective and preventative action is proposed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This is report 1 of 3.
Event or Problem Description
It was reported that two non-locking cortical screws got loose at biplanar 2-column plate approx.6 weeks post-operatively.This is report 1 of 3.

• Brand Name: BIPLANAR 2-COLUMN PLATE, 12-HOLE, LEFT, PRS PHOENIX
• Common Device Name: BIPLANAR 2-COLUMN PLATE, 12-HOLE, LEFT, PRS PHOENIX
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhöhe, 8301 ; AU 8301
• MDR Report Key: 17196044
• Report Number: 3004369035-2023-00100
• Device Sequence Number: 18007782
• Product Code: HRS
• UDI-Device Identifier: 09120069816990
• UDI-Public: 09120069816990
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K210935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

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: 21216-12
• Device Catalogue Number: 21216-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG