MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-12 for WASHER, 13MM 175710130 manufactured by Medos International Sàrl Ch.
[120264407]
Product complaint (b)(4). (b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[120264408]
Depuy synthes received a voice mail from (b)(6), sales rep, reporting that during a laminectomy procedure on (b)(6) 2018 metal pieces of device 175710535 and 175710130 broke off in the patient. He stated that this came from the teeth. The surgery was completed successfully and patient was not harmed. The surgeon was upset that this occurred. Synthes created (b)(4) for the documentation of this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50877 |
| MDR Report Key | 7870037 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-12 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-08-16 |
| Date Added to Maude | 2018-09-12 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WASHER, 13MM |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2018-09-12 |
| Model Number | 175710130 |
| Catalog Number | 175710130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-12 |