MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2015-06-26 for 8114505 manufactured by Medtronic Sofamor Danek Usa, Inc.
[6264925]
It was reported that, patient underwent a plif at l3 to l5. At the time of bending a multi-span plate with a pair of plate bender, one of plate benders was broken at the tip. The physician continued plate bending procedure with the same bender and the surgery was successfully completed. As a result of the incident, the surgical time was extended less than 15 minutes. The breakage occurred while the physician applied the force to bend the plate. After the incident, the dimple located near the grip end was used instead of the broken part. The fragment remained in the patient? S body. However, no health damage was reported. The product was not used in the patient.
Patient Sequence No: 1, Text Type: D, B5
[13705954]
(b)(4): the device has been returned to the manufacturer for evaluation. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete.
Patient Sequence No: 1, Text Type: N, H10
[14151345]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[25518544]
Product analysis observations:a corner on the sleeved end of the bender has broken off. Microscopic review reveals a fairly brittle fracture that appears to emanate from the inside of the bender. The fracture face is consistent with that of sudden overload and not fatigue. Conclusion: the above observations are consistent with material overload.
Patient Sequence No: 1, Text Type: N, H10
[100166217]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-01305 |
| MDR Report Key | 4870569 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2015-06-26 |
| Date of Report | 2015-08-17 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-08-17 |
| Device Manufacturer Date | 2013-01-14 |
| Date Added to Maude | 2015-06-26 |
| 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 | GREG ANGLIN |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-06-26 |
| Returned To Mfg | 2015-06-19 |
| Model Number | NA |
| Catalog Number | 8114505 |
| Lot Number | NM12F004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-26 |