FDA Adverse Event
Injury
Summary report: N
PECTUS STABILIZER
MDR report key: 278164
·
Received May 10, 2000
Report
- Report Number
- 1032347-2000-00007
- Event Type
- Injury
- Date Received
- May 10, 2000
- Date of Event
- February 24, 2000
- Report Date
- April 12, 2000
- Manufacturer
- WALTER LORENZ SURGICAL, INC.
- Product Code
- HRS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 1998 THE PATIENT UNDERWENT SURGERY TO CORRECT A PECTUS EXCAVATUM DEFORMITY. PATIENT WAS SEEN ON 9/22/1998 BY SURGEON AND COMPLAINED OF PAIN AT THAT TIME. THE DOCTOR NOTED ASSYMETRY OF CHEST AND PATIENT RECEIVED A CAT SCAN. DOCTOR DID NOT SEE PATIENT AGAIN. ON 2/24/2000 PATIENT WAS SEEN BY A DIFFERENT PHYSICIAN AND IT WAS DETERMINED THAT THE PECTUS BAR STABILIZER HAD BROKEN. PATIENT DID NOT KNOW WHEN THE PLATE BROKE. REVISION SURGERY WAS PERFORMED IN 2000 TO CORRECT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PECTUS STABILIZER | PLATE | HRS | WALTER LORENZ SURGICAL, INC. | NA | 503060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |