MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-08 for BONE PROBE CURVED LENKE PSSPCL manufactured by Precision Spine, Inc..
[166381774]
Occupation - other: distributor. Review of device history record found twenty-five (25) pieces of lot 529641 were released for distribution on (b)(6) 2011 with no deviation or anomalies. Two-year complaint history review did not identify a trend for reports of this nature. Information provided indicates that the product is available for evaluation but has yet to be received by the manufacturer. Should the product be received a follow-up medwatch report will be submitted following completion of evaluation.
Patient Sequence No: 1, Text Type: N, H10
[166381775]
During a procedure performed in the (b)(6), utilizing the s-lok posterior lumbar pedicle screw system, the bone probe (psspcl) broke at the transition. Another instrument that was readily available was used to complete the procedure with no injury to patient and a slight delay of approximately ten minutes to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005739886-2019-00017 |
| MDR Report Key | 8767447 |
| Date Received | 2019-07-08 |
| Date of Report | 2019-06-17 |
| Date of Event | 2019-06-17 |
| Date Mfgr Received | 2019-06-17 |
| Device Manufacturer Date | 2011-05-24 |
| Date Added to Maude | 2019-07-08 |
| 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 | MIKE DAWSON |
| Manufacturer Street | 2050 EXECUTIVE DR |
| Manufacturer City | PEARL MS 39208 |
| Manufacturer Country | US |
| Manufacturer Postal | 39208 |
| Manufacturer Phone | 6014204244 |
| Manufacturer G1 | PRECISION SPINE, INC. |
| Manufacturer Street | 2050 EXECUTIVE DR |
| Manufacturer City | PEARL MS 39208 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 39208 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE PROBE CURVED LENKE |
| Generic Name | BONE PROBE |
| Product Code | HXB |
| Date Received | 2019-07-08 |
| Returned To Mfg | 2019-07-18 |
| Catalog Number | PSSPCL |
| Lot Number | 529641 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION SPINE, INC. |
| Manufacturer Address | 2050 EXECUTIVE DR PEARL MS 39208 US 39208 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-08 |