FDA Adverse Event
Injury
Summary report: N
TI DISTAL EXTENSION
MDR report key: 2032579
·
Received March 23, 2011
Report
- Report Number
- 2530088-2011-00080
- Event Type
- Injury
- Date Received
- March 23, 2011
- Report Date
- February 28, 2011
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MDI
- PMA / PMN Number
- H03009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
PT IMPLANTED WITH BI-LATERAL VEPTR II ON (B)(6) 2010. PT HAD REGULAR LENGTHENING PROCEDURE INVOLVING PLACEMENT OF ONE RIB SLEEVE AND DISTRACTION LOCK ON (B)(6) 2011. STATUS POST, PT DEVELOPED INFECTION AND HARDWARE WAS EXPLANTED ON THE RIGHT SIDE RIB TO ILIUM ON (B)(6)2011. THIS IS THE 6TH OF 6 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI DISTAL EXTENSION | VEPTR IMPLANT | MDI | SYNTHES BRANDYWINE | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention | S-HOOK| DISTRACTION LOCK| PROXIMAL EXTENSION| PARALLEL CONNECTOR| RIB HOOK |