MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for NARROW POSTERIOR TAMP, 25MM 279755602 manufactured by Medos International Sàrl Ch.
[145237788]
(b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation 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
[145237789]
The surgeon was using the vertebral body tamp from the expedium osteotomy set as it was intended. He was malleting on the back of the instrument while the footed tamp was snuggle placed in between the spinal cord and posterior wall of the l4 vertebral body. While malleting, the footed portion to the 25mm tamp broke insitu. Fortunately, the patient was not harmed during this failure and the broken instrument fragment was recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51636 |
| MDR Report Key | 8607492 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2016-06-20 |
| Date Added to Maude | 2019-05-14 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NARROW POSTERIOR TAMP, 25MM |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-04-29 |
| Model Number | 279755602 |
| Catalog Number | 279755602 |
| Lot Number | GB73391 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-14 |