MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-24 for LACTOSORB SYSTEM 14MM RAPID FLAP N/A 915-0020 manufactured by Biomet Microfixation.
[188258617]
(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Concomitant medical products: baxter fibrin sealant patch, part# ni, lot# ni; johnson and johnson evical fibrin sealant, part# ni, lot# ni; unknown pds sutures, part# ni, lot# ni. The user facility is foreign; therefore, a facility medwatch report will not be available. Report source:? (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[188258618]
It was reported the bio-absorbable cranial fixation clamps fractured intra-operatively during a infratentorial craniotomy. Another pack of bone clamps was opened but were found in an unusable condition. The fascia sutures, fibrin patch and fibrin sealant that were already in place were removed to facilitate removal of the fractured cranial fixation clamps, resulting in a 20 minute delay. The patient was closed with pds sutures. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00185 |
| MDR Report Key | 9872164 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2018-05-22 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER DELANEY |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACTOSORB SYSTEM 14MM RAPID FLAP |
| Generic Name | PLATE, BONE |
| Product Code | JEY |
| Date Received | 2020-03-24 |
| Model Number | N/A |
| Catalog Number | 915-0020 |
| Lot Number | 615760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-24 |