FDA Adverse Event
Injury
Summary report: N
PKG. 6MM X 23MM STRYKER BIOSTEON SCREW
MDR report key: 6933287
·
Received October 9, 2017
Report
- Report Number
- 0002936485-2017-00939
- Event Type
- Injury
- Date Received
- October 9, 2017
- Date of Event
- August 29, 2017
- Report Date
- December 20, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- MBI
- PMA / PMN Number
- K151314
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. (B)(4).
Additional Manufacturer Narrative · 1
THIS IS BEING FILED ON BEHALF OF THE LEGAL MANUFACTURER BIOCOMPOSITES LTD. (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THE SCREW BROKE DURING MEDICAL PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED THE SCREW BROKE DURING MEDICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707657 | PKG. 6MM X 23MM STRYKER BIOSTEON SCREW | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE | MBI | STRYKER ENDOSCOPY-SAN JOSE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Other |