MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM 289706000 manufactured by Depuy Spine Inc.
[185613781]
(b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes rep. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. 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
[185613782]
Device report from synthes reports an event in (b)(6) as follows: the procedure was an acdf, and uniplate was used. The torque handle is damaged and caused the torque to snap while carrying out the final tightening. The procedure was delayed by 5-10 minutes as we had to source another kit and use the handle and shaft from there. Didn? T affect the patient outcomes though and the patient wasn? T harmed in the process. This was also not a clinical trial. The surgeon went to final tighten the cam loc on the plate and he torque handle normally clicks to let him know he? S turned it enough - this failed to happen causing the shaft to snap into the lock. Concomitant device reported: unknown screws (part#: unknown, lot#: unknown, quantity: 1). This complaint involves two (2) devices. This report is for one (1) uniplate anterior cervical plate system. This report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00755 |
| MDR Report Key | 9873312 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
| Generic Name | TRI-LOBE CAM TIGHTENER SHAFT |
| Product Code | HWR |
| Date Received | 2020-03-24 |
| Model Number | 289706000 |
| Catalog Number | 289706000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |