MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-29 for AIRFLO VEST TALL-INTL AF102W manufactured by Depuy Synthes Spine.
[93851656]
Product complaint # (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
[93851657]
Account name: (b)(6) hospital the reported product was used in hangman fracture surgery with the vest (af102w) on (b)(6) 2017. Approximately ten days after the surgery, the connecting section by the use of a clamp and a screw had become loose. So, the surgeon performed spine fixation, set up the vest again without a problem on (b)(6). It was reported that the clamp could hold the vest securely. The surgery was delayed by 60 minutes. There was no adverse consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2017-50025 |
| MDR Report Key | 7068680 |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-27 |
| Device Manufacturer Date | 2016-07-21 |
| Date Added to Maude | 2017-11-29 |
| 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 | 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 | AIRFLO VEST TALL-INTL |
| Generic Name | UNKNOWN |
| Product Code | IQF |
| Date Received | 2017-11-29 |
| Returned To Mfg | 2017-11-28 |
| Catalog Number | AF102W |
| Lot Number | 059830 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-29 |