MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-28 for BONE-LOK PLS IMPLANT 9024-00 LSW-45-3040 manufactured by Interventional Spine, Inc..
[17146202]
After implanting a facet screw, a subcomponent, known as the pull pin, was prematurely disengaged. The screw was not fully compressed, so the surgeon used another instrument, known as the driver, to fully seat the implant against the bone. The procedure was completed with no adverse affect to the pt. The surgeon implanted 6 screws in total; 2 of the 6 screws had pull pins that prematurely disengaged during compression of the implant. It should be noted that on (b)(6) 2009, the complaint was evaluated for possible reporting, and the decision not to report was made. Upon re-review, it was decided that this event should be reported. It should also be noted that this complaint is similar in nature to 2032499-2011-0001 and 2032499-2011-00002.
Patient Sequence No: 1, Text Type: D, B5
[17319342]
The pull pin is a component that is threaded into the facet screw. After threading the screw into the bone, the pull pin is grabbed with an instrument known as a compression tool; the pull pin is held while the instrument compressed the screw head against the bone, achieving a locked position. The pull pin is then unthreaded and removed from the screw. After compressing the screw, the pull pin prematurely disengaged. The surgeon then used another tool to further screw the implant, fully seating it. The procedure was then completed with no adverse impact on the pt. The investigation revealed that the pull pin supplier mfg the thread on the pull pin. 003" smaller than the lower specification limit. The screw, supplied by another vendor, mfg the mating screw threads at nominal. With the pull pin smaller than required, the locking mechanism was compromised. The pull pin supplier has now been changed and the current supplier now mfrs both the pull pin and the mating screw.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00005 |
| MDR Report Key | 2045654 |
| Report Source | 07 |
| Date Received | 2011-02-28 |
| Date of Report | 2009-07-02 |
| Date of Event | 2009-06-22 |
| Date Mfgr Received | 2009-07-02 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2012-02-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 13700 ALTON PKWY. SUITE 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2032499-0112511-001 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE-LOK PLS IMPLANT |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Model Number | 9024-00 |
| Catalog Number | LSW-45-3040 |
| Lot Number | 050709-A |
| Device Expiration Date | 2012-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-02-28 |