MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-09-13 for THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 3.5 MM N/A 91-6703 manufactured by Biomet Microfixation.
[120160762]
(b)(4). Device product code: hbw. (b)(4). Concomitant medical device: biomet microfixation thinflap 2-hole straight plate, thinflap, catalog #: 19-1005, lot #: ni; oxford performance materials htr-pekk sullivan right posterior parietal implant catalog #: ox621096, lot #: 202978-001. Therapy date: (b)(6) 2018. Customer has indicated that the product will not be returned to zimmer biomet for investigation, the product was discarded. 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: 0001032347-2018-00617.
Patient Sequence No: 1, Text Type: N, H10
[120160763]
It was reported a revision of the cranioplasty implant was performed due to a cerebral spinal fluid leak. There was no alleged failure of the implant to perform as intended and no indication that the implant contributed to the need for re-operation. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00618 |
| MDR Report Key | 7873337 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-09-13 |
| Date of Report | 2019-02-27 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2019-02-08 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2018-09-13 |
| 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 | THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 3.5 MM |
| Generic Name | FASTENER, SCREW, CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2018-09-13 |
| Model Number | N/A |
| Catalog Number | 91-6703 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-09-13 |