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

Model Number	21191-14
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initially the lot number was not provided, but after discussion with distributor we have received the lot number from the plate and screw.We have inspected the dhf of these batches and no deviation was detected.Furthermore, we have performed an analysis of 4 screws and 1 plate with the same lot number we had on stock and no deviation was detected.As a result of the above and the fact that no device was returned for evaluation, this complaint is deemed unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This is report 2 of 2.
Event or Problem Description
It was reported that a locking 4.2mm cancellous screw didn't lock in a curved prs rx plate and was screwed through the plate hole.This is report 2 of 2.

• Brand Name: CURVED PLATE, 14-HOLE, PRS RX SYSTEM
• Common Device Name: CURVED PLATE, 14-HOLE, PRS RX SYSTEM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 12352929
• Report Number: 3004369035-2021-00072
• Device Sequence Number: 19826906
• Product Code: HRS
• UDI-Device Identifier: 09120034309687
• UDI-Public: 09120034309687
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 21191-14
• Device Catalogue Number: 21191-14
• Device Lot Number: 26/F42765
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR