MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-23 for MOD LENKE PROBE ASSEMBLY 698341387 manufactured by Depuy Spine Inc.
[163821915]
(b)(4). The 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
[163821916]
It was reported that on (b)(6) 2019, during spinal fusion procedure the custom gear shift broke in the patient while cannulating ilium for pelvic screw. There was a surgical delay of fifteen (15) minutes. The procedure was successfully completed. Fragments were generated and were not removed easily. Patient status is unknown. Concomitant medical products: unknown pelvic screw (part# unknown, lot# unknown, quantity unknown). This complaint involves one (1) device.
Patient Sequence No: 1, Text Type: D, B5
[176715724]
Product complaint (b)(4). Udi (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2019-52126 |
| MDR Report Key | 9104538 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-23 |
| Date of Report | 2019-08-27 |
| Date of Event | 2019-08-27 |
| Date Mfgr Received | 2019-11-13 |
| Device Manufacturer Date | 2014-09-18 |
| Date Added to Maude | 2019-09-23 |
| 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 SPINE INC |
| 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 | 3 |
| Brand Name | MOD LENKE PROBE ASSEMBLY |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-09-23 |
| Returned To Mfg | 2019-10-30 |
| Catalog Number | 698341387 |
| Lot Number | DP0914 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2019-09-23 |