FDA Adverse Event
Malfunction
Summary report: N
ARRAY IMPLANTS
MDR report key: 2179840
·
Received July 27, 2011
Report
- Report Number
- 2242816-2011-00095
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- June 11, 2011
- Report Date
- June 28, 2011
- Manufacturer
- EBI, LLC
- Product Code
- KWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS 1 OF 4 MDRS RELATED TO THE SAME EVENT. PLEASE SEE MDR NUMBERS: 2242816-2011-00094, 2242816-2011-00095, 2242816-2011-00096.
Additional Manufacturer Narrative · 1
THIS IS 3 OF 4 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR NUMBERS:2242816-2011-00083,2242816-2011-00094,2242816-2011-00096.
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO SCREWS FRACTURED AND TWO SET SCREWS WERE DAMAGED DURING THE SURGERY. THE PROCEDURE WAS COMPLETED WITH OTHER SCREWS. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARRAY IMPLANTS | 30 HEXAGLOBE SET SCREW | KWP | EBI, LLC | 763370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |