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 2017-08-10 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes Usa.
[82456358]
Original implant date is unknown, primary operation was performed 17 years prior. Device is not expected to be returned for manufacturer review/investigation. (b)(6). Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[82456359]
Device report from synthes on an event in (b)(6) as follows: it was reported about a procedure: removal of posterior instrumented fusion. Patient was operated by a general orthopaedic surgeon on the (b)(6) 2017, the primary operation was performed 17 years prior. Both rods were broken and as this was a removal of implants for a l5/s1 spondylolisthesis that they were unable to remove the l5 screws due to the difficult access to the l5 pedicles. Consequently the below has been left insitu: side 1: pedicles screw/artial rod/sleeve. Side 2: pedicles screw/partial rod/sleev/nut. The surgeon removed the s1 left and right pedicles screw, sleeves, nuts and a cross connector. The broken rods were removed also, however, the surgeon was unable to remove the l5 left and right pedicle screws, sleeves and could only remove a nut on one side, moreover, in both l5 screws, part of the uss 6mm rod are still captured. The surgeon believed that the pain the patient was experiencing was due to the broken rods and was not concerned that there was still implants insitu as he indicated that they were solid. This case was purely a removal and the surgeon did not revise with any other implants. All available information has been provided as part of this report, no further information will be forthcoming. This case is not being reported by the customer, but a jjm employee. This complaint involves one part. Concomitant parts reported: 4x screws, part unk, lot unk, 2x unknown spine, part unk, lot unk, unk quantity of nuts, part unk, lot unk, unk quantity of sleeve, part unk, lot unk. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12068 |
| MDR Report Key | 6784899 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-10 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-08-10 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2017-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-10 |