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 2020-03-13 for DXTEND SCREW LOCK D4.5X36MM 130790036 manufactured by Depuy France Sas - 3003895575.
[186527556]
(b)(4). 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
[186527557]
After the locking screw had been placed, the surgeon noticed that the locking bolt was no longer placed inside the screw. The locking bolt fell on the ground. The team tried to use the locking bolt of another locking screw, but it did not solve the problem. The size 36 had to be removed and a new one was placed to complete the procedure. There was a ten-minute surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[188143413]
Product complaint #: (b)(4). Investigation summary: the returned product was examined and no manufacturing or design defect was found. The reason for failure was undetermined. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. 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
| Report Number | 1818910-2020-07910 |
| MDR Report Key | 9832380 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-10-24 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY FRANCE SAS 3003895575 |
| Manufacturer Street | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 |
| Manufacturer City | SAINT PRIEST CEDEX 69801 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXTEND SCREW LOCK D4.5X36MM |
| Generic Name | DELTA XTEND IMPLANTS : SCREWS |
| Product Code | HSD |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 130790036 |
| Catalog Number | 130790036 |
| Lot Number | 5354590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY FRANCE SAS - 3003895575 |
| Manufacturer Address | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |