MAUDE Adverse Event Report: I.T.S. GMBH J-PLATE, 14-HOLE, PRS RX SYSTEM

Model Number	21197-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have inspected the qc documents of the affected batch and the quality inspection forms as well as the material certificates showed no deviations and complies with the specifications.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.Further information - x-rays, patient data,.Was not provided, but already requested.As soon further information from the hospital/distributor gets available a follow-up report will be submitted.
Event or Problem Description
It was reported that a pelvic j-plate broke approx.9 months post-op.

• Brand Name: J-PLATE, 14-HOLE, PRS RX SYSTEM
• Common Device Name: J-PLATE, 14-HOLE, PRS RX SYSTEM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 12164575
• Report Number: 3004369035-2021-00006
• Device Sequence Number: 17131692
• Product Code: HRS
• UDI-Device Identifier: 09120047300039
• UDI-Public: 09120047300039
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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: 21197-14
• Device Catalogue Number: 21197-14
• Device Lot Number: 86/499897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 07/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention