PINN CAN BONE SCREW 6.5MMX25MM
Received Sep 14, 2020 · Event occurred Aug 31, 2020
Report 1818910-2020-20015 · MDR key 10531081
Device
Generic name
Bone Screws And Pins : Screws
Manufacturer
Depuy Orthopaedics Inc UsModel number
1217-25-500Catalog number
121725500
Lot number
D18113266
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- No Code Available
- Pain
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
THE PATIENT WAS REVISED TO ADDRESS PAIN, AS PER SURGEON HE WANTS TO CHANGE POSITION OF THE CUP. NO FURTHER INFORMATION PROVIDED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT HIP.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.