FDA Adverse Event
Injury
Summary report: N
REFLEXION TOE SYSTEM
MDR report key: 1508378
·
Received October 9, 2009
Report
- Report Number
- 2027754-2009-00009
- Event Type
- Injury
- Date Received
- October 9, 2009
- Date of Event
- September 17, 2009
- Report Date
- October 9, 2009
- Manufacturer
- OSTEOMED L.P.
- Product Code
- LZJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS NOT EXPECTED TO BE RETURNED TO COMPANY. THIS INFO IS BASED ON VERBAL INTERVIEW OF SURGEON.
Description of Event or Problem · 1
PT IMPLANTED IN 2008. APPROX 4 WEEKS POSTOP, PT SHOWED SIGNS OF WARMTH OR REDNESS AROUND IMPLANT SITE. NO COMPLAINTS MADE TO COMPANY AT THAT TIME. ON 9/9/2009, THE REP WAS INFORMED THAT THE PT WAS TO BE RE-OPERATED. THE PT HAD BEEN PUT ON IV ANTIBIOTICS IN INTERVENING PERIOD, ALTHOUGH, ALL BLOOD CULTURES AND BONE BIOPSIES WERE NEGATIVE FOR INFECTION. DOCTOR INDICATED HE BELIEVES PT HAD AN ALLERGIC REACTION TO IMPLANT BECAUSE SHE "HAD SENSITIVITY TO CERTAIN TYPES OF EARRINGS" GOING BACK SEVERAL YEARS. THE IFU CAUTIONS AGAINST USE OF THE PRODUCT IN PTS WITH KNOWN METAL SENSITIVITIES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED IN THE LAST YEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REFLEXION TOE SYSTEM | 1ST MPJ JOINT | LZJ | OSTEOMED L.P. | 370-0423 | 1021716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | AT THE TIME OF IMPLANT| THESE PRODUCTS ARE USED AS A SYSTEM| LOT# 370-0203| 370-0223, LOT #1021298 |