PINN CAN BONE SCREW 6.5MMX25MM
Received Nov 12, 2020 · Event occurred Oct 28, 2020
Report 1818910-2020-24406 · MDR key 10828860
Device
Generic name
Bone Screws And Pins : Screws
Manufacturer
Depuy Orthopaedics Inc UsModel number
1217-25-500Catalog number
121725500
Lot number
D19113807
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR
- Unspecified Infection
- No Code Available
- Unspecified Infection
- No Code Available
Narrative
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. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
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
IT WAS REPORTED THAT REMOVAL OF ALL IMPLANTS AND PLACEMENT OF ANTIBIOTIC SPACER DUE TO INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT SIDE.