MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-03-20 for 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW N/A 915-2315 manufactured by Biomet Microfixation.
[102858017]
Zimmer biomet complaint (b)(4). Concomitant medical products: biomet microfixation 1. 5 x 4 mm lactosorb screw catalog #: 915-2315 lot #: 756970, biomet microfixation 2. 0 x 5 mm lactosorb screw catalog #: 915-2300 lot #: 801350, unknown 5mm drill catalog #: ni lot #: ni, unknown 6mm tap catalog #: ni lot #: ni. Therapy date: (b)(6) 2017. Report source: foreign country - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, they were discarded by the facility. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00131 and 0001032347-2018-00132.
Patient Sequence No: 1, Text Type: N, H10
[102858018]
It was reported the fixed first and second screws fractured or came out of the patient's temporal bone when the surgeon attempted to insert the third screw to fix the square plate. After that, the surgeon drilled and tapped using the 5mm drill and the 6mm tap, when he attempted to insert the screw fixation could not be achieved the screw idly rotated. The surgery was complete using surgical sutures to fix the autogenous bone and bone flap without any delay. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00133 |
| MDR Report Key | 7352244 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-03-20 |
| Date of Report | 2018-06-29 |
| Date of Event | 2017-11-29 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2017-06-05 |
| Date Added to Maude | 2018-03-20 |
| 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. MICHELLE COLE |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW |
| Generic Name | BONE SCREW; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
| Product Code | NHB |
| Date Received | 2018-03-20 |
| Model Number | N/A |
| Catalog Number | 915-2315 |
| Lot Number | 828000 |
| ID Number | (01)00841036055189 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2018-03-20 |