FDA Adverse Event
Malfunction
Summary report: N
ALTA TRAN/TIB/HUM/SC 3.7X30MM
MDR report key: 138047
·
Received December 11, 1997
Report
- Report Number
- 2219689-1997-00714
- Event Type
- Malfunction
- Date Received
- December 11, 1997
- Report Date
- December 10, 1997
- Manufacturer
- HOWMEDICA, INC.
- Product Code
- HSB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: METALLURGICAL ANALYSIS RESULTS SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE. HOWEVER, THERE IS INSUFFICIENT INFO PROVIDED IN THE PER TO DETERMINE THE CAUSE FOR THE FRACTURE OF THE ALTA TRANSVERSE SCREW IN FATIGUE.
Description of Event or Problem · 1
PATIENT HAD AN ALTA TIBIAL ROD AND THREE SCREWS IMPLANTED ON JANUARY 21, 1996. IN MAY 1996, IT WAS DISCOVERED THAT THE PROXIMAL SCREW HAD BROKEN. MAY 28,1996, AN ATTEMPT WAS MADE TO REMOVE THE BROKEN SCREW. THE ATTEMPT WAS UNSUCCESSFUL AS THE HEAD OF THE SCREW WAS IMBEDDED IN BONE. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTA TRAN/TIB/HUM/SC 3.7X30MM Implant | IMPLANT | HSB | HOWMEDICA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | ALTA TIBIAL ROD & ALTA DISTAL SCREWS |