FDA Adverse Event
Malfunction
Summary report: N
BIOSYN
MDR report key: 14281998
·
Received May 4, 2022
Report
- Report Number
- 9612501-2022-00723
- Event Type
- Malfunction
- Date Received
- May 4, 2022
- Report Date
- May 3, 2022
- Manufacturer
- DAVIS & GECK CARIBE LTD
- Product Code
- GAM
- UDI-DI
- 10884521033115
- PMA / PMN Number
- K000037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MIF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
ACCORDING TO THE REPORTER, DURING OPEN SPINE PROCEDURE, AT THE FINAL SKIN CLOSURE, BOTH NEEDLES DETACHED FROM THE THREAD BROKE FOR TWO SUTURES. TO RESOLVE THE ISSUE, THE STAFF OPENED ANOTHER SUTURE AND THE NEEDLE STAYED ON THE THREAD. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409701 | BIOSYN | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC | GAM | DAVIS & GECK CARIBE LTD | SM-5679G | 10884521033115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |