FDA Adverse Event
Malfunction
Summary report: N
SHORELINE
MDR report key: 13015625
·
Received December 16, 2021
Report
- Report Number
- 3012120772-2021-00088
- Event Type
- Malfunction
- Date Received
- December 16, 2021
- Date of Event
- November 9, 2021
- Report Date
- December 15, 2021
- Manufacturer
- SEASPINE, INC
- Product Code
- OVE
- UDI-DI
- 10889981162696
- PMA / PMN Number
- K210497
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS: BENDING, DISASSEMBLY OR FRACTURE OF IMPLANT AND COMPONENTS. INTRAOPERATIVE WARNINGS: BREAKAGE, SLIPPAGE, OR MISUSE OF INSTRUMENTS OR IMPLANT COMPONENTS MAY CAUSE INJURY TO THE PATIENT OR OPERATIVE PERSONNEL.
Description of Event or Problem · 0
ON (B)(6) 2021, SURGEON USED A SHORELINE INSERTER (86-0012) TO IMPLANT A WAVEFORM C IMPLANT. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DISTAL TIP OF THE SHORELINE INSERTER HAD SNAPPED OFF AND THE FRAGMENT REMAINED IN THE INTERBODY. THE SURGERY WAS NOTED TO HAVE COMPLETED WITH NO COMPLICATIONS. IT IS UNKNOWN IF ALL FRAGMENTS WERE REMOVED AND ACCOUNTED FOR. UNKNOWN IF FRAGMENTS WERE REMOVED AND ACCOUNTED FOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1916463 | SHORELINE | INSERTER, STRAIGHT | OVE | SEASPINE, INC | 86-0012 | BT059045B | 10889981162696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | WAVEFORM C |